CompletedNot Applicable

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

Germany, Netherlands44 participantsStarted 2021-06-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

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

Timeframe: 1 day (day of intervention)

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

Timeframe: 1 day (day of intervention)

Trial details

NCT IDNCT04700410

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-28

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