About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

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

Clinicaltrials.gov identifier NCT03922906

Recruitment Status Recruiting

First Posted April 22, 2019

Last update posted February 26, 2020

Study Description

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.

  • Condition or Disease:CRC
  • Intervention/Treatment: Device: Pure-Vu System
  • Phase: N/A
Detailed Description

The study is planned as a single arm, open trial will include up to 30 patients, 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. Subjects will be enrolled at up to 3 clinical sites in Israel. Subjects who meet the eligibility criteria will be required to follow a standard bowel preparation instruction. 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 C) and 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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 30 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Screening
  • Official Title: Evaluation of Bowel Cleansing Using the Pure-Vu System in Patients With History of Inadequate Bowel Preparation
  • Actual Study Start Date: January 2020
  • Estimated Primary Completion Date: January 2021
  • Estimated Study Completion Date: January 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Motus Pure-Vu System
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
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.
Outcome Measures
  • Primary Outcome Measures: 1. Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of Pure-Vu System [ Time Frame: Up to 2 hours ]
    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
Eligibility Criteria
  • Ages Eligible for Study: 22 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

1. Subjects with history of inadequate bowel preparation.

2. Subjects in the age range of 22-75 years inclusive

3. Subjects with BodyMass Index (BMI) within the range of 18.5-35 inclusive

4. Subject has signed the informed consent

Exclusion Criteria:

1. Patients with active Inflammatory Bowel Disease

2. Patients with previous history of acute diverticulitis disease or with prior
incomplete colonoscopy due to diverticular disease

3. Patients with known bowel obstruction / strictures

4. History of prior surgery to colon and/or rectum

5. ASA ≥ III

6. Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)

7. Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical
history)

8. Patients taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy

9. Patients with known coagulation disorder (INR >1.5).

10. Patients at risk of hypokalemia or hyponatremia

11. Patients with congestive cardiac failure

12. Pregnancy (as stated by patient) or breast feeding

13. Patients with altered mental status/inability to provide informed consent

14. Patients who have participated in another interventional clinical study in the last 2
months

Contacts and Locations
Contacts

Contact: Ravit Peled 0526145354 ravit@motusgi.com

Locations

Israel
Chaim Sheba Medical Center
Tel Hashomer

Sponsors and Collaborators

Motus GI Medical Technologies Ltd

More Information
  • Responsible Party: Motus GI Medical Technologies Ltd
  • ClinicalTrials.gov Identifier: NCT03922906 History of Changes
  • Other Study ID Numbers: CL00046
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: February 26, 2020
  • Last Verified: November 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No