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出境医 / 临床实验 / Evaluation of Bowel Cleansing Using the Pure-Vu System in Patients With History of Inadequate Bowel Preparation

Evaluation of Bowel Cleansing Using the Pure-Vu System in Patients With History of Inadequate Bowel Preparation

Study Description
Brief Summary:
The study aim to evaluate the performance of Pure-Vu System in cleansing patients' colon with history of inadequate bowel preparation who are indicated for a colonoscopy procedure.

Condition or disease Intervention/treatment Phase
CRC Device: Pure-Vu System Not Applicable

Detailed Description:

The study is planned as a single arm, open trial will include up to 30 patients, aim to evaluate the performance of Pure-Vu System in cleansing patients' colon with history of inadequate bowel preparation who are indicated for a colonoscopy procedure.

Subjects will be enrolled at up to 3 clinical sites in Israel. Subjects who meet the eligibility criteria will be required to follow a standard bowel preparation instruction. Patients will be asked to record and provide their diet and bowel movements in the provided diary log at time of their scheduled colonoscopy (Diary log is provided in appendix C) and to complete a satisfaction questionnaire include feedback on the procedure and on specific aspects related to the preparation regime.

Following the procedure a telephone follow-up will be conducted at 48 hours (± 48 hours) post Pure-Vu procedure to assess patient well-being and capture any adverse events.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of Bowel Cleansing Using the Pure-Vu System in Patients With History of Inadequate Bowel Preparation
Actual Study Start Date : January 21, 2020
Actual Primary Completion Date : February 25, 2020
Actual Study Completion Date : February 2, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Motus Pure-Vu System
The Pure-Vu System enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.
 Device: Pure-Vu System
Pure-Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating and/or cleaning the colon and evacuating the irrigation fluid (saline water), feces and other bodily fluids and matter, e.g. blood.
Outcome Measures
Primary Outcome Measures :
  1. Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of Pure-Vu System [ Time Frame: Up to 2 hours ]

    The rating of the cleansing quality was evaluated by using the Boston Bowel Preparation Scale (BBPS), Segment score of 0-3 given to each of the 3 segments of the colon (Left side, Transverse and right side):

    Score 0- Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.

    Score 1- A portion of the mucosa of the colon segment is seen, but other areas of the colon segment are not seen well due to staining, residual stool, and/or opaque liquid.

    Score 2- A minor amount of residual staining, small fragments of stool, and/or opaque liquid are visible, but the mucosa of the colon segment are seen well.

    Score 3-The entire mucosa of the colon segment is seen well with no residual staining, small fragments of stool, or opaque liquid.

    subject consider as having adequate cleaning if BBPS>1 in all colon segments



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects with history of inadequate bowel preparation.
  2. Subjects in the age range of 22-75 years inclusive
  3. Subjects with BodyMass Index (BMI) within the range of 18.5-35 inclusive
  4. Subject has signed the informed consent

Exclusion Criteria:

  1. Patients with active Inflammatory Bowel Disease
  2. Patients with previous history of acute diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
  3. Patients with known bowel obstruction / strictures
  4. History of prior surgery to colon and/or rectum
  5. ASA ≥ III
  6. Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)
  7. Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)
  8. Patients taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy
  9. Patients with known coagulation disorder (INR >1.5).
  10. Patients at risk of hypokalemia or hyponatremia
  11. Patients with congestive cardiac failure
  12. Pregnancy (as stated by patient) or breast feeding
  13. Patients with altered mental status/inability to provide informed consent
  14. Patients who have participated in another interventional clinical study in the last 2 months
Contacts and Locations

Locations
Layout table for location information
Israel
Chaim Sheba Medical Center
Tel Hashomer, Israel, 5265601
Sponsors and Collaborators
Motus GI Medical Technologies Ltd
Tracking Information
First Submitted Date  ICMJE April 18, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date February 25, 2021
Actual Study Start Date  ICMJE January 21, 2020
Actual Primary Completion Date February 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019) 		Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of Pure-Vu System [ Time Frame: Up to 2 hours ]
The rating of the cleansing quality was evaluated by using the Boston Bowel Preparation Scale (BBPS), Segment score of 0-3 given to each of the 3 segments of the colon (Left side, Transverse and right side): Score 0- Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. Score 1- A portion of the mucosa of the colon segment is seen, but other areas of the colon segment are not seen well due to staining, residual stool, and/or opaque liquid. Score 2- A minor amount of residual staining, small fragments of stool, and/or opaque liquid are visible, but the mucosa of the colon segment are seen well. Score 3-The entire mucosa of the colon segment is seen well with no residual staining, small fragments of stool, or opaque liquid. subject consider as having adequate cleaning if BBPS>1 in all colon segments
Original Primary Outcome Measures  ICMJE Same as current
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 Evaluation of Bowel Cleansing Using the Pure-Vu System in Patients With History of Inadequate Bowel Preparation
Official Title  ICMJE Evaluation of Bowel Cleansing Using the Pure-Vu System in Patients With History of Inadequate Bowel Preparation
Brief Summary The study aim to evaluate the performance of Pure-Vu System in cleansing patients' colon with history of inadequate bowel preparation who are indicated for a colonoscopy procedure.
Detailed Description

The study is planned as a single arm, open trial will include up to 30 patients, aim to evaluate the performance of Pure-Vu System in cleansing patients' colon with history of inadequate bowel preparation who are indicated for a colonoscopy procedure.

Subjects will be enrolled at up to 3 clinical sites in Israel. Subjects who meet the eligibility criteria will be required to follow a standard bowel preparation instruction. Patients will be asked to record and provide their diet and bowel movements in the provided diary log at time of their scheduled colonoscopy (Diary log is provided in appendix C) and to complete a satisfaction questionnaire include feedback on the procedure and on specific aspects related to the preparation regime.

Following the procedure a telephone follow-up will be conducted at 48 hours (± 48 hours) post Pure-Vu procedure to assess patient well-being and capture any adverse events.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE CRC
Intervention  ICMJE Device: Pure-Vu System
Pure-Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating and/or cleaning the colon and evacuating the irrigation fluid (saline water), feces and other bodily fluids and matter, e.g. blood.
Study Arms  ICMJE Experimental: Motus Pure-Vu System
The Pure-Vu System enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.
Intervention: Device: Pure-Vu System
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 Terminated
Actual Enrollment  ICMJE
 (submitted: February 23, 2021) 		3
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2019) 		30
Actual Study Completion Date  ICMJE February 2, 2021
Actual Primary Completion Date February 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects with history of inadequate bowel preparation.
  2. Subjects in the age range of 22-75 years inclusive
  3. Subjects with BodyMass Index (BMI) within the range of 18.5-35 inclusive
  4. Subject has signed the informed consent

Exclusion Criteria:

  1. Patients with active Inflammatory Bowel Disease
  2. Patients with previous history of acute diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
  3. Patients with known bowel obstruction / strictures
  4. History of prior surgery to colon and/or rectum
  5. ASA ≥ III
  6. Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)
  7. Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)
  8. Patients taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy
  9. Patients with known coagulation disorder (INR >1.5).
  10. Patients at risk of hypokalemia or hyponatremia
  11. Patients with congestive cardiac failure
  12. Pregnancy (as stated by patient) or breast feeding
  13. Patients with altered mental status/inability to provide informed consent
  14. Patients who have participated in another interventional clinical study in the last 2 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 75 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 Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03922906
Other Study ID Numbers  ICMJE CL00046
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
Plan to Share IPD: No
Responsible Party Motus GI Medical Technologies Ltd
Study Sponsor  ICMJE Motus GI Medical Technologies Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Motus GI Medical Technologies Ltd
Verification Date February 2021

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

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