TerminatedNot Applicable

Clinical and Urgent Colonoscopy Outcomes Using the Pure-Vu® Cleansing System

Stopped: Difficulty recruiting

United States6 participantsStarted 2021-03-03

Plain-language summary

The Pure-Vu® System can be effectively used as a cleansing device in patients admitted with acute LGIB to the intensive care unit and the regular nurse floor (RNF) bypassing the need to administer an oral bowel preparation for adequate visualization and hence decreasing time to colonoscopy and improving diagnostic and therapeutic yield.

Who can participate

Age range

22 Years

Sex

ALL

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: * Hospitalized patients in the ICU or the RNF with acute LGIB (defined as maroon-colored stool or bright red blood per rectum with suspicion of acute blood loss anemia, and hemodynamically stable and/or stabilized at the time of procedure . Hospitalized patients include: * Patients who develop LGIB while admitted for different reasons * Patients transferred from an outside hospital for further management of acute LGIB * Patients admitted through the emergency room for management of acute LGIB * At least 22 years old * Undergoing urgent colonoscopy under monitored anesthesia care or conscious sedation Exclusion Criteria: * Suspicion for bowel obstruction/ stricture * Toxic megacolon or severe colitis (determined by degree of colitis on imaging and clinical condition including pain, fevers, abdominal exam, elevated inflammatory markers) * Active Diverticulitis

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adequate Bowel Preparation

Timeframe: During the colonoscopy procedure, typically less than 1 hour

Trial details

NCT IDNCT04729946

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-06

View on ClinicalTrials.gov More Lower Gastrointestinal Bleeding trials