NCT04285008

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Motus GI Medical Technologies Ltd · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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.

Detailed description

Total of 88 subjects (44 per arm) at high risk for inadequate colon preparation will be randomized and undergo procedure either in the Control arm (standard of care) or with the Pure-Vu System. Subjects will be enrolled at up to 4 clinical sites in the United States. primary endpoint- 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) The following secondary endpoints will be determined: 1. Assess the willingness of consented subjects to pay for Pure-Vu prior to colonoscopy 2. Colonoscopy procedural measures for Intervention and Control arms 3. Endoscopists' experience 4. Safety assessment for all subjects on the day of procedure per endoscopist 5. Post-colonoscopy patient experience and safety check with scripted phone call 1-3 days after colonoscopy 6. Assess the willingness of consented subjects to pay for the Pure-Vu System 1-3 days after colonoscopy Follow-up call will be conducted 1-3 business days after the procedure to verify that there has been no change in their clinical status and record their willingness to use the Pure-Vu System in the future.

Conditions

• Gastrointestinal Disease
• Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	Pure-Vu System	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.

Timeline

• Start date: 2020-03-03
• Primary completion: 2021-04-01
• Completion: 2021-04-15
• First posted: 2020-02-26
• Last updated: 2020-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study