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

NCT04285008 | Withdrawn FDA Device

• 1 other identifier: CL00048
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Disease; Colorectal Cancer

Keywords

colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

standard Colonoscopy

NO INTERVENTION

Control arm Colonoscopy procedure using standard flushing and suctioning - standard of care

Pure-Vu System

OTHER

Intervention - Colonoscopy procedure using Pure-Vu System

Device: Pure-Vu System

Interventions

Pure-Vu System 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.

Pure-Vu System

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Motus GI Medical Technologies Ltd: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 26, 2020
• Study Start: March 3, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 15, 2021
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)