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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Gastrointestinal Disease
• Intervention / Treatment: Device: Pure-Vu System

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Hospitalized patients who are indicated for a screening, diagnostic, surveillance or therapeutic colonoscopy
2. Patients' age > 22 years
3. Patient has signed the informed consent

Exclusion Criteria:

1. Patients with known Inflammatory Bowel Disease and / or active Colitis
2. Patients with active diverticulitis
3. Patients with known or detected (during colonoscopy) bowel obstruction
4. Patients with BMI ≤ 18
5. Patients with ascites Child Pugh C
6. Patients who are 30 days post-transplant
7. Patients treated with Peritoneal dialysis
8. Patients under active IV inotropic medications
9. Patients with LVAD
10. Patients who have active anticoagulant medications (excluding aspirin) or dual antiplatelet therapy in their system prior to the procedure. (Note: to avoid exclusion therapy should be discontinued 48 hours or greater prior to the procedure based on discretion of physician)
11. Subjects with known coagulation disorder (INR ≥ 2 or platelets <50,000)
12. Subjects with hemodynamic instability.
13. Pregnancy (as stated by patient) or breast feeding
14. Subjects with altered mental status/inability to provide informed consent
15. Patients who have participated in another interventional clinical study in the last 2 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colonoscopy with Pure-Vu System; Standard colonoscopy procedure with Pure-Vu System	Device: Pure-Vu System; The Pure-Vu System is FDA cleared device and CE marking received in February 2018, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System	The rate of adequate cleansing level in each colon segment before and after use of Pure-Vu will be evaluated 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) summed for the maximum score of 9 (0= dirtiest and 9= pristine). An adequate cleansing procedure will be considered when all the colon segments will be graded as 2 or above.	up to 2 hours

Collaborators and Investigators

• Sponsor: Motus GI Medical Technologies Ltd
• Investigators: Study Director: Annie Choi, Motus GI Technologies Ltd.

Publications and helpful links

General Publications

• Neumann H, Latorre M, Zimmerman T, Lang G, Samarasena J, Gross S, Brahmbhatt B, Pazwash H, Kushnir V. A multicenter, prospective, inpatient feasibility study to evaluate the use of an intra-colonoscopy cleansing device to optimize colon preparation in hospitalized patients: the REDUCE study. BMC Gastroenterol. 2021 May 22;21(1):232. doi: 10.1186/s12876-021-01817-2.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2018
• Primary Completion (Actual): May 20, 2019
• Study Completion (Actual): May 20, 2019

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: bowel prepartion
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: CL00044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: no plan to share the individual participated date with other researchers at this point.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes