Status:
WITHDRAWN
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
Lead Sponsor:
Motus GI Medical Technologies Ltd
Conditions:
Gastrointestinal Disease
Colorectal Cancer
Eligibility:
All Genders
22+ years
Phase:
NA
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 prepa...
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. Subje...
Eligibility Criteria
Inclusion
- Adults \> age 22
- Elective outpatient colonoscopy by participating gastroenterologist
- Stool clarity grade 1-3 at presentation for colonoscopy
Exclusion
- Not competent to consent
- Bleeding disorder - known or suspected
- Hereditary Gastrointestinal Cancer syndrome
- Known PT INR \> 1.5
- Know elevated PTT
- Anti-platelet agent or anticoagulant (other than aspirin or nonsteroidal agent) which has not been stopped for the colonoscopy
- Known platelet count \< 50,000
- Known absolute neutrophil count \< 1,000
- History of surgical colon resection
- Pre-colonoscopy intent to enter terminal ileum
- Prior incomplete colonoscopy due to technical \& non-bowel preparation related reasons
- Regular use of non-topical steroid
- Pregnant
- Prisoner or institutionalized for any reason
- Psychiatric illness greater than mild
- Colonoscopy without anesthesia administered (MAC) sedation
- Diverticulitis
- Active inflammatory bowel disease (Crohn's, Ulcerative Colitis, or Indeterminate)
- Known or suspected colon stricture
Key Trial Info
Start Date :
March 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04285008
Start Date
March 3 2020
End Date
April 15 2021
Last Update
June 25 2020
Active Locations (1)
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1
Washington University in St. Louis
St Louis, Missouri, United States, 63110