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

Withdrawn before enrolling · Not applicable

Conditions studied: Gastrointestinal Disease, Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT04285008

Run by

Motus GI Medical Technologies Ltd

People needed

0

Starts

2020-03-03

Expected to finish

2021-04-15

Last updated by the study team

2020-06-25

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

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
• Colonoscopy without anesthesia administered (MAC) sedation
• Diverticulitis
• Active inflammatory bowel disease (Crohn's, Ulcerative Colitis, or Indeterminate)
• Known or suspected colon stricture

Where it is running

• Washington University in St. Louis — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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