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出境医 / 临床实验 / The Second-Generation MCCG for Upper Gastrointestinal Tract.

The Second-Generation MCCG for Upper Gastrointestinal Tract.

Study Description
Brief Summary:
The aim of this study is to evaluate the clinical application of the second-generation MCCG with higher image resolution and frame rate for upper gastrointestinal tract compared with the first-generation.

Condition or disease Intervention/treatment Phase
Capsule Endoscopy Device: the second-generation MCCG Not Applicable

Detailed Description:

Magnetically controlled capsule gastroscopy (MCCG) has been widely used in clinical practice for gastric examination. However, there still exist blind spots under MCCG, particularly in the esophagus and duodenum. Although the anatomy of the esophagus and duodenum can be the main cause, MCCG still needs technical improvement. In addition, the gastric examination time under MCCG can be further optimized.

Therefore, a new-generation MCCG is developed with a higher frame rate improved from 0.5-2 to 0.5-8 frames per second, image resolution improved from 480 x 480 to 720 x 720, view angle improved from 140° to 150°, wireless anti-jamming technology is applied as a more effective and stable information transmission method.

This is a prospective, single-centered, blinded randomized controlled pilot study. Subjects receiving MCCG at Changhai Hospital will be randomly allocated into two groups with a ratio of 1:1 before the procedure, the first-generation or the second-generation MCCG. After passage through the esophagus, the gastric examination and transpyloric passage of the capsule is conducted under magnetic steering, and then examination is continued in the small bowel under intestinal peristalsis.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Second-generation Versus First-generation Magnetically Controlled Capsule Gastroscopy for Upper Gastrointestinal Tract: a Randomized Controlled Clinical Trial.
Actual Study Start Date : May 10, 2019
Actual Primary Completion Date : July 18, 2019
Actual Study Completion Date : July 25, 2019
Arms and Interventions
Arm Intervention/treatment
No Intervention: The first-generation MCCG group
The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
Experimental: The second-generation MCCG group
All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
Device: the second-generation MCCG
Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).

Outcome Measures
Primary Outcome Measures :
  1. Circumferential Visualization of the Z-line [ Time Frame: Through end of examination, up to 30 minutes ]
    Circumferential visualization of the Z-line is defined by quadrants as follows: less than 2 quadrants (< 50%) of the Z line observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (>75%) observed; and entire Z line (100%) observed.


Secondary Outcome Measures :
  1. Detection Rate of Duodenal Papilla [ Time Frame: up to 2 days after the examination ]
    Detection rate of duodenal papilla means the percentage of patients with at least one image of duodenal papilla was obtained

  2. Gastric Examination Time (GET) [ Time Frame: Through end of examination, up to 30 minutes ]
    Record the time taken for endoscopist to finish the gastric examination for primary anatomical landmarks twice (cardia, fundus, body, angulus, antrum and pylorus).

  3. Manipulation Performance Score of the MCCG [ Time Frame: up to 10 minutes after the examination ]
    The performance of maneuverability is assessed using a semi-quantitative score related to the fluency, stability and comfortableness for examination procedure. Fluency is mainly reflected on the response speed to operation and smoothness of video playing. Stability is about the ability of holding the position for a long enough time and the real-time viewing of all images. comfortableness is the operator's sensation about manipulative force and fatigue degree. Maneuverability score was defined as a total scale of 3 to 15 calculated by adding up each evaluation index score above, and each index was graded from 1 to 5, with 1 as the worst and 5 as the best.

  4. Image Quality Score (Mainly Focus on Clarity) [ Time Frame: up to 30 minutes after the examination ]
    Assess Image quality grade ranged from 1 to 10 (1, the worst quality; 10, the quality of the best image captured by EGD).

  5. The Number of Images Captured for Esophagus and Z-line [ Time Frame: up to 30 minutes after the examination ]
    The number of images captured by MCCG for esophagus and Z-line.

  6. Number of Participants With Lesions in Upper Gastrointestinal Tract [ Time Frame: up to 2 days after the examination ]
    calculate the number of participants with lesions in different part of upper gastrointestinal tract (esophagus, stomach, duodenum, jejunoileum), and preliminarily evaluate the diagnostic efficacy of the new-generation MCCG.

  7. Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time [ Time Frame: up to 2 days after the examination ]
    Assess the transit time of MCCG in the gastrointestinal tract (stomach and small bowel), and record the total running time from starts take images to ends.

  8. Cleansing Level Score of Z-line Area [ Time Frame: Through end of examination, up to 30 minutes ]
    The bubbles/saliva on the Z line area will be scored as follows: 0 = no bubbles/saliva on the Z line area;1 = a few bubbles/saliva on the Z line area; 2= increased amount of bubbles/saliva on the Z line area; 3 = severe bubbles/saliva on the Z line area.

  9. The Incidence of Adverse Events (The Safety of MCCG) [ Time Frame: up to 2 weeks after the examination ]
    The presence of adverse events within two weeks aftter swallowing MCCG will be recorded.

  10. Transit Time of MCCG in Esophagus [ Time Frame: up to 2 days after the examination ]
    Assess the transit time of MCCG in esophagus from starts take images to ends.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • With or without gastrointestinal complaints
  • Scheduled to undergo a capsule endoscopy for both stomach and small bowel
  • Signed the informed consents before joining this study

Exclusion Criteria:

  • Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy
  • Refused abdominal surgery to take out the capsule in case of capsule retention
  • Implanted pacemaker, except the pacemaker is compatible with MRI
  • Other implanted electromedical devices or magnetic metal foreign bodies
  • Pregnancy or suspected pregnancy
Contacts and Locations

Locations
Layout table for location information
China
Changhai Hospital
Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
Tracking Information
First Submitted Date  ICMJE June 3, 2019
First Posted Date  ICMJE June 6, 2019
Results First Submitted Date  ICMJE July 27, 2020
Results First Posted Date  ICMJE October 27, 2020
Last Update Posted Date October 27, 2020
Actual Study Start Date  ICMJE May 10, 2019
Actual Primary Completion Date July 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2020)
Circumferential Visualization of the Z-line [ Time Frame: Through end of examination, up to 30 minutes ]
Circumferential visualization of the Z-line is defined by quadrants as follows: less than 2 quadrants (< 50%) of the Z line observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (>75%) observed; and entire Z line (100%) observed.
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
Circumferential visualization of the Z-line and Detection rate of duodenal papilla [ Time Frame: up to 2 weeks ]
Circumferential visualization of the Z-line is defined by quadrants as follows: less than 2 quadrants (< 50%) of the Z line observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (>75%) observed; and entire Z line (100%) observed. Detection rate of duodenal papilla means that at least one image of duodenal papilla was obtained.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2020)
  • Detection Rate of Duodenal Papilla [ Time Frame: up to 2 days after the examination ]
    Detection rate of duodenal papilla means the percentage of patients with at least one image of duodenal papilla was obtained
  • Gastric Examination Time (GET) [ Time Frame: Through end of examination, up to 30 minutes ]
    Record the time taken for endoscopist to finish the gastric examination for primary anatomical landmarks twice (cardia, fundus, body, angulus, antrum and pylorus).
  • Manipulation Performance Score of the MCCG [ Time Frame: up to 10 minutes after the examination ]
    The performance of maneuverability is assessed using a semi-quantitative score related to the fluency, stability and comfortableness for examination procedure. Fluency is mainly reflected on the response speed to operation and smoothness of video playing. Stability is about the ability of holding the position for a long enough time and the real-time viewing of all images. comfortableness is the operator's sensation about manipulative force and fatigue degree. Maneuverability score was defined as a total scale of 3 to 15 calculated by adding up each evaluation index score above, and each index was graded from 1 to 5, with 1 as the worst and 5 as the best.
  • Image Quality Score (Mainly Focus on Clarity) [ Time Frame: up to 30 minutes after the examination ]
    Assess Image quality grade ranged from 1 to 10 (1, the worst quality; 10, the quality of the best image captured by EGD).
  • The Number of Images Captured for Esophagus and Z-line [ Time Frame: up to 30 minutes after the examination ]
    The number of images captured by MCCG for esophagus and Z-line.
  • Number of Participants With Lesions in Upper Gastrointestinal Tract [ Time Frame: up to 2 days after the examination ]
    calculate the number of participants with lesions in different part of upper gastrointestinal tract (esophagus, stomach, duodenum, jejunoileum), and preliminarily evaluate the diagnostic efficacy of the new-generation MCCG.
  • Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time [ Time Frame: up to 2 days after the examination ]
    Assess the transit time of MCCG in the gastrointestinal tract (stomach and small bowel), and record the total running time from starts take images to ends.
  • Cleansing Level Score of Z-line Area [ Time Frame: Through end of examination, up to 30 minutes ]
    The bubbles/saliva on the Z line area will be scored as follows: 0 = no bubbles/saliva on the Z line area;1 = a few bubbles/saliva on the Z line area; 2= increased amount of bubbles/saliva on the Z line area; 3 = severe bubbles/saliva on the Z line area.
  • The Incidence of Adverse Events (The Safety of MCCG) [ Time Frame: up to 2 weeks after the examination ]
    The presence of adverse events within two weeks aftter swallowing MCCG will be recorded.
  • Transit Time of MCCG in Esophagus [ Time Frame: up to 2 days after the examination ]
    Assess the transit time of MCCG in esophagus from starts take images to ends.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Gastric Examination Time (GET) [ Time Frame: up to 2 weeks ]
    Record the time taken for endoscopist to finish the gastric examination for primary anatomical landmarks twice (cardia, fundus, body, angulus, antrum and pylorus).
  • Manipulation Performance Score of the MCCG [ Time Frame: up to 2 weeks ]
    The performance of maneuverability is assessed using a semi-quantitative score related to the fluency, stability and easiness for examination procedure. Fluency is mainly reflected on the response speed to operation and smoothness of video playing. Stability is about the ability of holding the position for a long enough time and the real-time viewing of all images. Easiness is the operator's sensation about manipulative force and fatigue degree. Maneuverability score was defined as a scale of 1 to 5 for each evaluation index above (1, the worst operation experience; 5, the most comfortable operation experience).
  • Image Quality Score (Mainly Focus on Clarity) [ Time Frame: up to 2 weeks ]
    Assess Image quality grade ranged from 1 to 10 (1, the worst quality; 10, the quality of the best image captured by EGD).
  • The Number of Images Captured for Esophagus and Z-line [ Time Frame: up to 2 weeks ]
    The number of images captured by MCCG for esophagus and Z-line.
  • Detection rate of lesions in upper gastrointestinal tract [ Time Frame: up to 2 weeks ]
    Assess the detection rate of lesions in different part of UGIT (esophagus, stomach, duodenum, jejunoileum), and preliminarily evaluate the diagnostic efficacy of the new-generation MCCG.
  • Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time [ Time Frame: up to 2 weeks ]
    Assess the transit time of MCCG in the gastrointestinal tract (esophagus, stomach, small bowel), and record the total running time from starts take images to ends.
  • Cleansing Level Score of Z-line Area [ Time Frame: up to 2 weeks ]
    The effect of bubbles/saliva on the appearance of the Z line area will be scored as follows: 0 = no interference by bubbles/saliva on the Z line area;1 = minor interference of bubbles/saliva on the Z line area; 2 = major interference of bubbles/saliva on the Z line area.
  • The Incidence of Adverse Events (The Safety of MCCG) [ Time Frame: up to 2 weeks ]
    The presence of adverse events during MCCG procedure will be recorded.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Second-Generation MCCG for Upper Gastrointestinal Tract.
Official Title  ICMJE Second-generation Versus First-generation Magnetically Controlled Capsule Gastroscopy for Upper Gastrointestinal Tract: a Randomized Controlled Clinical Trial.
Brief Summary The aim of this study is to evaluate the clinical application of the second-generation MCCG with higher image resolution and frame rate for upper gastrointestinal tract compared with the first-generation.
Detailed Description

Magnetically controlled capsule gastroscopy (MCCG) has been widely used in clinical practice for gastric examination. However, there still exist blind spots under MCCG, particularly in the esophagus and duodenum. Although the anatomy of the esophagus and duodenum can be the main cause, MCCG still needs technical improvement. In addition, the gastric examination time under MCCG can be further optimized.

Therefore, a new-generation MCCG is developed with a higher frame rate improved from 0.5-2 to 0.5-8 frames per second, image resolution improved from 480 x 480 to 720 x 720, view angle improved from 140° to 150°, wireless anti-jamming technology is applied as a more effective and stable information transmission method.

This is a prospective, single-centered, blinded randomized controlled pilot study. Subjects receiving MCCG at Changhai Hospital will be randomly allocated into two groups with a ratio of 1:1 before the procedure, the first-generation or the second-generation MCCG. After passage through the esophagus, the gastric examination and transpyloric passage of the capsule is conducted under magnetic steering, and then examination is continued in the small bowel under intestinal peristalsis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Capsule Endoscopy
Intervention  ICMJE Device: the second-generation MCCG
Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
Study Arms  ICMJE
  • No Intervention: The first-generation MCCG group
    The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
  • Experimental: The second-generation MCCG group
    All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
    Intervention: Device: the second-generation MCCG
Publications * Jiang B, Qian YY, Pan J, Jiang X, Wang YC, Zhu JH, Zou WB, Zhou W, Li ZS, Liao Z. Second-generation magnetically controlled capsule gastroscopy with improved image resolution and frame rate: a randomized controlled clinical trial (with video). Gastrointest Endosc. 2020 Jun;91(6):1379-1387. doi: 10.1016/j.gie.2020.01.027. Epub 2020 Jan 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 25, 2019
Actual Primary Completion Date July 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • With or without gastrointestinal complaints
  • Scheduled to undergo a capsule endoscopy for both stomach and small bowel
  • Signed the informed consents before joining this study

Exclusion Criteria:

  • Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy
  • Refused abdominal surgery to take out the capsule in case of capsule retention
  • Implanted pacemaker, except the pacemaker is compatible with MRI
  • Other implanted electromedical devices or magnetic metal foreign bodies
  • Pregnancy or suspected pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03977935
Other Study ID Numbers  ICMJE SG-MCCG-UGT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhuan Liao, Changhai Hospital
Study Sponsor  ICMJE Changhai Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Changhai Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP