Colorectal Cancer, Gastrointestinal Disease
Conditions
Keywords
colonoscopy
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.
Interventions
DEVICEPure-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.
Sponsors
Motus GI Medical Technologies Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
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.
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.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of adequate cleansing level after using the Pure-Vu System as compare to sandard of care colonoscopy procedure | 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) |
Countries
United States
Outcome results
None listed