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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-03

Study Completion Date

2021-04-15

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.

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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:

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.

Conditions

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Gastrointestinal Disease Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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standard Colonoscopy

Control arm

Colonoscopy procedure using standard flushing and suctioning - standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Pure-Vu System

Intervention - Colonoscopy procedure using Pure-Vu System

Group Type OTHER

Pure-Vu System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes