Evaluation of Bowel Cleansing Using the Pure-Vu System in Patients With History of Inadequate Bowel Preparation

NCT03922906 | Terminated

• 1 other identifier: CL00046
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The study aim to evaluate the performance of Pure-Vu System in cleansing patients' colon with history of inadequate bowel preparation who are indicated for a colonoscopy procedure.

Conditions

CRC

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of Pure-Vu System

  The rating of the cleansing quality was evaluated by using the Boston Bowel Preparation Scale (BBPS), Segment score of 0-3 given to each of the 3 segments of the colon (Left side, Transverse and right side): Score 0- Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. Score 1- A portion of the mucosa of the colon segment is seen, but other areas of the colon segment are not seen well due to staining, residual stool, and/or opaque liquid. Score 2- A minor amount of residual staining, small fragments of stool, and/or opaque liquid are visible, but the mucosa of the colon segment are seen well. Score 3-The entire mucosa of the colon segment is seen well with no residual staining, small fragments of stool, or opaque liquid. subject consider as having adequate cleaning if BBPS\>1 in all colon segments

  Up to 2 hours

Study Arms (1)

Motus Pure-Vu System

EXPERIMENTAL

The Pure-Vu System enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter \& fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.

Device: Pure-Vu System

Interventions

Pure-Vu System DEVICE

Pure-Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating and/or cleaning the colon and evacuating the irrigation fluid (saline water), feces and other bodily fluids and matter, e.g. blood.

Motus Pure-Vu System

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with history of inadequate bowel preparation.
• Subjects in the age range of 22-75 years inclusive
• Subjects with BodyMass Index (BMI) within the range of 18.5-35 inclusive
• Subject has signed the informed consent

You may not qualify if:

• Patients with active Inflammatory Bowel Disease
• Patients with previous history of acute diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
• Patients with known bowel obstruction / strictures
• History of prior surgery to colon and/or rectum
• ASA ≥ III
• Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)
• Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)
• Patients taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy
• Patients with known coagulation disorder (INR \>1.5).
• Patients at risk of hypokalemia or hyponatremia
• Patients with congestive cardiac failure
• Pregnancy (as stated by patient) or breast feeding
• Patients with altered mental status/inability to provide informed consent
• Patients who have participated in another interventional clinical study in the last 2 months

Sponsors & Collaborators

• Motus GI Medical Technologies Ltd: lead

Study Sites (1)

Chaim Sheba Medical Center

Tel Litwinsky, 5265601, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 22, 2019
• Study Start: January 21, 2020
• Primary Completion: February 25, 2020
• Study Completion: February 2, 2021
• Last Updated: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)