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Randomized Controlled Study Comparing Colon Evaluation With The Pure-Vu System To A Standard Colonoscopy In Patients Who Are High Risk For Inadequate Bowel Preparation (RESCue)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04285008
Recruitment Status : Withdrawn (Sponsor has terminated study due to COVID-19 related concerns)
First Posted : February 26, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Motus GI Medical Technologies Ltd

Tracking Information
First Submitted Date  ICMJE February 24, 2020
First Posted Date  ICMJE February 26, 2020
Last Update Posted Date June 25, 2020
Actual Study Start Date  ICMJE March 3, 2020
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2020)
rate of adequate cleansing level after using the Pure-Vu System as compare to sandard of care colonoscopy procedure [ Time Frame: Up to 2 hours ]
A comparison between the two study arms (i.e., Pure-Vu vs. standard colonoscopy) of the rate of overall cleansing as well as cleansing per segment will be evaluated by the BBPS scoring index (Bowel preparation adequacy defined as BBPS >2 in each segment)
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 Randomized Controlled Study Comparing Colon Evaluation With The Pure-Vu System To A Standard Colonoscopy In Patients Who Are High Risk For Inadequate Bowel Preparation
Official Title  ICMJE Randomized Controlled Study Comparing Colon Evaluation With The Pure-Vu System To A Standard Colonoscopy In Patients Who Are High Risk For Inadequate Bowel Preparation
Brief Summary The primary objective of this multi-center, prospective, randomized controlled trial is to evaluate the bowel cleansing after Pure-Vu use in outpatient subjects at high risk for inadequate colon preparation as compare to standard of care.
Detailed Description

Total of 88 subjects (44 per arm) at high risk for inadequate colon preparation will be randomized and undergo procedure either in the Control arm (standard of care) or with the Pure-Vu System.

Subjects will be enrolled at up to 4 clinical sites in the United States.

primary endpoint- A comparison between the two study arms (i.e., Pure-Vu vs. standard colonoscopy) of the rate of overall cleansing as well as cleansing per segment will be evaluated by the BBPS scoring index (Bowel preparation adequacy defined as BBPS >2 in each segment)

The following secondary endpoints will be determined:

  1. Assess the willingness of consented subjects to pay for Pure-Vu prior to colonoscopy
  2. Colonoscopy procedural measures for Intervention and Control arms
  3. Endoscopists' experience
  4. Safety assessment for all subjects on the day of procedure per endoscopist
  5. Post-colonoscopy patient experience and safety check with scripted phone call 1-3 days after colonoscopy
  6. Assess the willingness of consented subjects to pay for the Pure-Vu System 1-3 days after colonoscopy

Follow-up call will be conducted 1-3 business days after the procedure to verify that there has been no change in their clinical status and record their willingness to use the Pure-Vu System in the future.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomization to Intervention or Control arm will use stratification by site, endoscopist and blocking. Sites are expected to contribute approximately equal numbers of procedures, and no site will be allowed to contribute more than 50% of the target sample size. The randomization sequences will be provided in advance by the study's statistician using an online system to obtain the randomization assignment and the corresponding colonoscope will be prepared. Randomization assignment will be recorded for each subject.
Masking: Single (Participant)
Masking Description:
The Colonoscope will be prepared as per normal routine and the research assistant will cover the colonoscope before the patient enters the endoscopy room to keep him/her blinded to the study arm. This is uncovered once the patient is sedated.
Primary Purpose: Screening
Condition  ICMJE
  • Gastrointestinal Disease
  • Colorectal Cancer
Intervention  ICMJE Device: Pure-Vu System
The Pure-Vu System is Food and Drug Administration (FDA) approved device (K191220), intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.
Study Arms  ICMJE
  • No Intervention: standard Colonoscopy

    Control arm

    Colonoscopy procedure using standard flushing and suctioning - standard of care

  • Pure-Vu System
    Intervention - Colonoscopy procedure using Pure-Vu System
    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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 23, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2020)
88
Estimated Study Completion Date  ICMJE April 15, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adults > age 22
  2. Elective outpatient colonoscopy by participating gastroenterologist
  3. Stool clarity grade 1-3 at presentation for colonoscopy

Exclusion Criteria:

  1. Not competent to consent
  2. Bleeding disorder - known or suspected
  3. Hereditary Gastrointestinal Cancer syndrome
  4. Known PT INR > 1.5
  5. Know elevated PTT
  6. Anti-platelet agent or anticoagulant (other than aspirin or nonsteroidal agent) which has not been stopped for the colonoscopy
  7. Known platelet count < 50,000
  8. Known absolute neutrophil count < 1,000
  9. History of surgical colon resection
  10. Pre-colonoscopy intent to enter terminal ileum
  11. Prior incomplete colonoscopy due to technical & non-bowel preparation related reasons
  12. Regular use of non-topical steroid
  13. Pregnant
  14. Prisoner or institutionalized for any reason
  15. Psychiatric illness greater than mild
  16. Colonoscopy without anesthesia administered (MAC) sedation
  17. Diverticulitis
  18. Active inflammatory bowel disease (Crohn's, Ulcerative Colitis, or Indeterminate)
  19. Known or suspected colon stricture
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04285008
Other Study ID Numbers  ICMJE CL00048
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: Yes
Product Manufactured in and Exported from the U.S.: 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 June 2020

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