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

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

Official Title
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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

Conditions
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Gastrointestinal Disease, Colorectal Cancer

Intervention / Treatment
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* Device: Pure-Vu System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults > age 22 Elective outpatient colonoscopy by participating gastroenterologist Stool clarity grade 1-3 at presentation for colonoscopy Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard Colonoscopy<br>Control arm Colonoscopy procedure using standard flushing and suctioning - standard of care | |
| Other: Pure-Vu System<br>Intervention - Colonoscopy procedure using Pure-Vu System | Device: Pure-Vu System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of adequate cleansing level after using the Pure-Vu System as compare to sandard of care colonoscopy procedure | 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) | Up to 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy