NCT03503162

Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Motus GI Medical Technologies Ltd · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the potential improvement in colonoscopy procedure's outcomes when using the Pure-Vu System in hospitalized patients who are indicated for colonoscopy procedure.

Detailed description

This multi-center, prospective, single arm study will include up to 100 patients (20-40 patients per site), aimed at evaluating the performance of the Pure-Vu System in cleansing hospitalized patients' colon who are indicated for standard colonoscopy procedure. Subjects will be enrolled at up to 4 clinical sites in the United States and Europe. Subjects who meet the eligibility criteria will be prescribed a standard bowel preparation bowel preparation regimen including diet restrictions and oral bowel preparation. Following the bowel preparation, the patient will undergo colonoscopy with the Pure-Vu system. In case of inadequate bowel preparation, as per the nurse report and / or BBPS \< 2, in at least one of the colon segments, prior Pure-Vu use, the physician will complete a questionnaire on the patient's management standard of care assuming the absence of Pure-Vu. Follow-up will be conducted at 48 hours (± 48 hours) post procedure.

Conditions

• Gastrointestinal Disease
• Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	Pure-Vu System	The Pure-Vu System is FDA cleared device and CE marking received in February 2018, 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: 2018-05-17
• Primary completion: 2019-05-20
• Completion: 2019-05-20
• First posted: 2018-04-19
• Last updated: 2021-04-13
• Results posted: 2021-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study