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出境医 / 临床实验 / Validation of Aer-O-Scope Colonoscope System Cecal Intubation

Validation of Aer-O-Scope Colonoscope System Cecal Intubation

Study Description
Brief Summary:
61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. The primary outcome is Cecal Intubation

Condition or disease Intervention/treatment Phase
Colonic Polyp Colonic Neoplasms Colonic Diseases Colon Adenoma Colon Disease Colon Adenocarcinoma Colon Cancer Device: Aer-O-Scope Colonoscopy Not Applicable

Detailed Description:

This will be a prospective single-center non-blinded clinical investigation. Each subject will undergo a colonoscopy to the cecum with the Aer-O-Scope Colonoscope System. All pathologies found will be removed. No control group is necessary as the main objective is to reach the cecum. Either the cecum is intubated or it is not. This is true for all colonoscopy procedures.

Up to the first ten (10) cases for each physician will be system operation training cases.

The primary endpoint of cecal intubation was chosen as this measure is the first quality objective when evaluating colonoscopy quality indicators.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A single group of subjects will undergo diagnostic, screening or surveillance colonoscopy.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Validation of Aer-O-Scope Colonoscope System Cecal Intubation
Actual Study Start Date : January 6, 2020
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Study Cohort
61 subjects will undergo colonoscopy
 Device: Aer-O-Scope Colonoscopy
resection or biopsy of colonic abnormalities for histopathalogical evaluation
Other Name: therapeutic intervention - polyp resection
Outcome Measures
Primary Outcome Measures :
  1. Aer-O-Scope Validation of Cecal Intubation [ Time Frame: 30 minutes ]
    The number of subjects for which cecal intubation will be achieved using the Aer-O-Scope Disposable Colonoscope


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject is indicated for screening, diagnostic (minor complaints such as rectal bleeding or minor abdominal pain) or surveillance colonoscopy
  2. Subject willing to undergo colon preparation bowel cleansing
  3. Subject between the ages of 45 and 75 (patients between the ages of 45 and 50 must have a family history of a first degree relative with onset of colon cancer before the age of 60).
  4. Subject is able to understand and willing to sign informed consent form

Exclusion Criteria:

  1. Personal history of colorectal neoplasia including familial adenomatous polyposis or hereditary nonpolyposis, colon cancer (HNPCC).
  2. Diagnosis of active (flaring) inflammatory bowel disease (active ulcerative colitis or Crohn's colitis), bowel obstruction, or acute diverticulitis, or known severe diverticulosis, fecal incontinence or any known large-bowel disease that would require a predetermined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases)
  3. Severe gastrointestinal tract-related symptoms, or complaints, suggesting performance of a pre-determined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases)
  4. History of colonic resection
  5. Clinically significant cardiovascular or pulmonary disease.
  6. Cancer or other life threatening disease or significant chronic condition that puts the subject at risk.
  7. Blood-clotting disorders and/or current anticoagulant therapy (Subjects taking up to 100mg aspirin for prophylactic treatment are acceptable for this study)
  8. Pregnancy
  9. Previous radiation therapy to the abdomen
  10. Morbid Obesity (BMI > 40 kg/m2)
  11. Drug abuse or alcoholism
  12. Subject is bed-ridden and/or unable to adequately communicate
  13. Subject is under custodial care
  14. Subject has a history of psychiatric disorders which would prevent compliance with study instructions
  15. Participation in a clinical study within the previous 30 days
Contacts and Locations

Contacts
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Contact: Sharon Goldfarb, BSc =972-54-6454034 sharon@giview.com

Locations
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Israel
Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Erwin Santo, MD    972-3-697-4969    nathang@tlvmc.gov.il   
Principal Investigator: Nathan Gluc, MD         
Sponsors and Collaborators
GI View Ltd.
Investigators
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Principal Investigator: Nathan Gluck, MD Tel Aviv Medical Center
Tracking Information
First Submitted Date  ICMJE April 28, 2019
First Posted Date  ICMJE May 14, 2019
Last Update Posted Date July 23, 2020
Actual Study Start Date  ICMJE January 6, 2020
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019) 		Aer-O-Scope Validation of Cecal Intubation [ Time Frame: 30 minutes ]
The number of subjects for which cecal intubation will be achieved using the Aer-O-Scope Disposable Colonoscope
Original Primary Outcome Measures  ICMJE
 (submitted: May 12, 2019) 		Aer-O-Scope Validation of Cecal Intubation [ Time Frame: 30 minutes ]
This study is intended to validate that the Aer-O-Scope Colonoscope System will be equivalent to conventional colonoscopy for intubation of the cecum, based on the intubation rate stated and known in the professional literature (95%)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation of Aer-O-Scope Colonoscope System Cecal Intubation
Official Title  ICMJE Validation of Aer-O-Scope Colonoscope System Cecal Intubation
Brief Summary 61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. The primary outcome is Cecal Intubation
Detailed Description

This will be a prospective single-center non-blinded clinical investigation. Each subject will undergo a colonoscopy to the cecum with the Aer-O-Scope Colonoscope System. All pathologies found will be removed. No control group is necessary as the main objective is to reach the cecum. Either the cecum is intubated or it is not. This is true for all colonoscopy procedures.

Up to the first ten (10) cases for each physician will be system operation training cases.

The primary endpoint of cecal intubation was chosen as this measure is the first quality objective when evaluating colonoscopy quality indicators.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
A single group of subjects will undergo diagnostic, screening or surveillance colonoscopy.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Colonic Polyp
  • Colonic Neoplasms
  • Colonic Diseases
  • Colon Adenoma
  • Colon Disease
  • Colon Adenocarcinoma
  • Colon Cancer
Intervention  ICMJE Device: Aer-O-Scope Colonoscopy
resection or biopsy of colonic abnormalities for histopathalogical evaluation
Other Name: therapeutic intervention - polyp resection
Study Arms  ICMJE Experimental: Study Cohort
61 subjects will undergo colonoscopy
Intervention: Device: Aer-O-Scope Colonoscopy
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 12, 2019) 		61
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2021
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is indicated for screening, diagnostic (minor complaints such as rectal bleeding or minor abdominal pain) or surveillance colonoscopy
  2. Subject willing to undergo colon preparation bowel cleansing
  3. Subject between the ages of 45 and 75 (patients between the ages of 45 and 50 must have a family history of a first degree relative with onset of colon cancer before the age of 60).
  4. Subject is able to understand and willing to sign informed consent form

Exclusion Criteria:

  1. Personal history of colorectal neoplasia including familial adenomatous polyposis or hereditary nonpolyposis, colon cancer (HNPCC).
  2. Diagnosis of active (flaring) inflammatory bowel disease (active ulcerative colitis or Crohn's colitis), bowel obstruction, or acute diverticulitis, or known severe diverticulosis, fecal incontinence or any known large-bowel disease that would require a predetermined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases)
  3. Severe gastrointestinal tract-related symptoms, or complaints, suggesting performance of a pre-determined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases)
  4. History of colonic resection
  5. Clinically significant cardiovascular or pulmonary disease.
  6. Cancer or other life threatening disease or significant chronic condition that puts the subject at risk.
  7. Blood-clotting disorders and/or current anticoagulant therapy (Subjects taking up to 100mg aspirin for prophylactic treatment are acceptable for this study)
  8. Pregnancy
  9. Previous radiation therapy to the abdomen
  10. Morbid Obesity (BMI > 40 kg/m2)
  11. Drug abuse or alcoholism
  12. Subject is bed-ridden and/or unable to adequately communicate
  13. Subject is under custodial care
  14. Subject has a history of psychiatric disorders which would prevent compliance with study instructions
  15. Participation in a clinical study within the previous 30 days
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sharon Goldfarb, BSc =972-54-6454034 sharon@giview.com
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03949777
Other Study ID Numbers  ICMJE 1056CLD
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No individual patient data will be shared
Responsible Party GI View Ltd.
Study Sponsor  ICMJE GI View Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nathan Gluck, MD Tel Aviv Medical Center
PRS Account GI View Ltd.
Verification Date July 2020

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

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