Bowel Cleansing Performance of the Pure-Vu System in Patients With a History of Poor Bowel Preparation

NCT04700410 | Completed

• 1 other identifier: NL66613.091.18
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 2

Brief Summary

The diagnostic accuracy and safety of colonoscopy highly depends on the quality of the pre-procedural bowel preparation. A past history of poor bowel preparation is the most important risk factor of inadequate bowel cleansing at the next colonoscopy. This study aims to evaluate if an adequate level of bowel cleansing can be achieved with the Pure-Vu System in patients with previous poor bowel preparation, in a single arm international multicenter feasibility study.

Conditions

Colorectal Cancer; Colonic Adenoma; Bowel Preparation

Keywords

Bowel preparation; colonoscopy; colorectal cancer; adenoma detection rate; endoscopy; therapeutic irrigation

Outcome Measures

Primary Outcomes (2)

• Boston Bowel Preparation scale (BBPS)-score before cleaning with the Pure-Vu system.

  Boston Bowel Preparation scale (BBPS): The adequacy of bowel preparation should be assessed after all appropriate efforts to clear residual debris is completed. All three bowel regions of the colon will be scored (i.e., the right colon, transverse colon, and left colon) from 0-3 points by the endoscopist. The segment scores are summed for a total BBPS ranging from 0 to 9. The points will be assigned as follows: 0\) Unprepared colon segment with mucosa not seen because of solid stool that could not be cleared. 1. Portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid. 2. Minor amount of residual staining, small fragments of stool, and/or opaque liquid but mucosa of colon segment seen well. 3. Entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. Each segment of the colon received a segmental score from 0- 3.

  1 day (day of intervention)

• Boston Bowel Preparation scale (BBPS)-score after cleaning with the Pure-Vu system.

  Boston Bowel Preparation scale (BBPS): The adequacy of bowel preparation should be assessed after all appropriate efforts to clear residual debris is completed. All three bowel regions of the colon will be scored (i.e., the right colon, transverse colon, and left colon) from 0-3 points by the endoscopist. The segment scores are summed for a total BBPS ranging from 0 to 9. The points will be assigned as follows: 0\) Unprepared colon segment with mucosa not seen because of solid stool that could not be cleared. 1. Portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid. 2. Minor amount of residual staining, small fragments of stool, and/or opaque liquid but mucosa of colon segment seen well. 3. Entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. Each segment of the colon received a segmental score from 0- 3.

  1 day (day of intervention)

Secondary Outcomes (9)

• Total number of colon lesions specified by histology

  1 day (day of intervention)

• Adenoma detection rate

  1 day (day of intervention)

• Cecal intubation rates

  1 day (day of intervention)

• Procedure times (total procedure time, cecal intubation time, withdrawal time, time for all other interventions)

  1 day (day of intervention)

• Total amount of water used for washing and total amount of fluids+residual stool removed.

  1 day (day of intervention)

Study Arms (1)

Pure-Vu

EXPERIMENTAL

All patients willing to participate will receive a limited bowel preparation (2-days of dietary restrictions + 2x 150ml picoprep) followed by intra-procedural bowel cleansing with the Pure-Vu System (single arm)

Device: Pure-Vu System

Interventions

Pure-Vu System DEVICE

All patients willing to participate will receive a limited bowel preparation (2-days of dietary restrictions + 2x 150ml picoprep) followed by intra-procedural bowel cleansing with the Pure-Vu System.

Pure-Vu

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients, aged between 18 and 80 years, referred and scheduled for either screening, diagnostic, or surveillance colonoscopy.
• Poor bowel preparation within the last 2 years, defined as a BBPS \<6 or need for repeat colonoscopy or shortening of surveillance interval due to poor bowel preparation

You may not qualify if:

• Prior colon resection
• Previous colorectal cancer
• Colitis
• Lower gastrointestinal bleeding with hemodynamic instability
• Bowel obstruction
• Pregnancy or lactating
• ASA \> 3
• Insufficiently corrected anticoagulation disorders
• Inability to provide informed consent

Sponsors & Collaborators

• Radboud University Medical Center: lead
• University Medical Center Mainz: collaborator
• Motus GI Medical Technologies Ltd: collaborator

Study Sites (2)

University Medical Center Mainz

Mainz, Germany

Location

Radboud university medical center

Nijmegen, Gelderland, 6525GA, Netherlands

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Independent assessment of BBPS (photos).
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single arm international multicenter colonoscopy trial

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: January 7, 2021
• Study Start: June 1, 2021
• Primary Completion: March 28, 2022
• Study Completion: May 1, 2022
• Last Updated: November 21, 2024

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Access Criteria: Data will be shared upon reasonable request

Locations

NL (1); DE (1)