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

Colorectal Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases

• NCT number: NCT03503162
• Study type: Interventional
• Source: Motus GI Medical Technologies Ltd
• Status: Completed
• Phase: N/A
• Start date: May 17, 2018
• Completion date: May 20, 2019