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

Primary Purpose

Gastrointestinal Disease, Colorectal Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pure-Vu System

About this trial

This is an interventional screening trial for Gastrointestinal Disease focused on measuring bowel prepartion

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Patients with known Inflammatory Bowel Disease and / or active Colitis
Patients with active diverticulitis
Patients with known or detected (during colonoscopy) bowel obstruction
Patients with BMI ≤ 18
Patients with ascites Child Pugh C
Patients who are 30 days post-transplant
Patients treated with Peritoneal dialysis
Patients under active IV inotropic medications
Patients with LVAD
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)
Subjects with known coagulation disorder (INR ≥ 2 or platelets <50,000)
Subjects with hemodynamic instability.
Pregnancy (as stated by patient) or breast feeding
Subjects with altered mental status/inability to provide informed consent
Patients who have participated in another interventional clinical study in the last 2 months

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Colonoscopy with Pure-Vu System

Arm Description

Standard colonoscopy procedure with Pure-Vu System

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03503162

First Posted

April 9, 2018

Last Updated

March 18, 2021

Sponsor

Motus GI Medical Technologies Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03503162

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

May 17, 2018 (Actual)

Primary Completion Date

May 20, 2019 (Actual)

Study Completion Date

May 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Motus GI Medical Technologies Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Disease, Colorectal Cancer

Keywords

bowel prepartion

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Colonoscopy with Pure-Vu System

Arm Type

Experimental

Arm Description

Standard colonoscopy procedure with Pure-Vu System

Intervention Type

Device

Intervention Name(s)

Pure-Vu System

Intervention Description

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.

Primary Outcome Measure Information:

Title

The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System

Description

Time Frame

up to 2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Hospitalized patients who are indicated for a screening, diagnostic, surveillance or therapeutic colonoscopy Patients' age > 22 years Patient has signed the informed consent Exclusion Criteria: Patients with known Inflammatory Bowel Disease and / or active Colitis Patients with active diverticulitis Patients with known or detected (during colonoscopy) bowel obstruction Patients with BMI ≤ 18 Patients with ascites Child Pugh C Patients who are 30 days post-transplant Patients treated with Peritoneal dialysis Patients under active IV inotropic medications Patients with LVAD 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) Subjects with known coagulation disorder (INR ≥ 2 or platelets <50,000) Subjects with hemodynamic instability. Pregnancy (as stated by patient) or breast feeding Subjects with altered mental status/inability to provide informed consent Patients who have participated in another interventional clinical study in the last 2 months

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Annie Choi

Organizational Affiliation

Motus GI Technologies Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

no plan to share the individual participated date with other researchers at this point.

Citations:

PubMed Identifier

34022813

Citation

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.

Results Reference

derived

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

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