NCT03493009

Optimizing the Preparation Regime Prior to Colonoscopy Procedure With Pure-Vu System

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Motus GI Medical Technologies Ltd · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this multicenter, prospective, randomized study is to evaluate the performance of Pure-Vu System in cleansing patients' colon who are indicated for a colonoscopy procedure using one of two different reduce bowel preparation regimes.in addition, the cecum intubation rate, time to cecum, total procedure time, and adverse event will be evaluated.

Detailed description

This multicenter, prospective, randomized study will include up to 100 patients (30 patients per site and 15 patients per study arm), aimed at evaluating the performance of Pure-Vu System in cleansing patients' colon who are indicated for colonoscopy procedure using one of two different preparation regimes as detailed below. Subjects will be enrolled at up to 10 clinical sites in the United States. Subjects who meet the eligibility criteria will be randomly allocated to a given study arm and will be required to follow a specific bowel preparation instruction along with a specific prep agent (Bowel preparation instructions for morning and afternoon procedures are provided in appendix B1 and B2, respectively), as per study arm allocation, starting 5 days prior to the colonoscopy with Pure-Vu. Patients will be asked to record and provide their diet and bowel movements in the provided diary log at time of their scheduled colonoscopy (Diary log is provided in appendix D). In addition patient will be ask to complete a satisfaction questionnaire include feedback on the procedure and on specific aspects related to the preparation regime. Following the procedure a telephone follow-up will be conducted at 48 hours (± 48 hours) post Pure-Vu procedure to assess patient well-being and capture any adverse events.

Conditions

• Gastrointestinal Diseases
• Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	Pure-Vu System	The Pure-Vu System is Food and Drug Administration (FDA) approved device since September 22, 2016, 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: 2018-05-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2018-04-10
• Last updated: 2018-10-31