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

NCT03493009 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-10-31

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Motus GI Medical Technologies Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2018-05-01
Completion
2018-05-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03493009 on ClinicalTrials.gov