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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503162
• Other study ID #: CL00044
• Status: Completed
• Phase: N/A
• Start date: May 17, 2018
• Est. completion date: May 20, 2019

Study information

• Verified date: October 2020
• Source: Motus GI Medical Technologies Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: May 20, 2019
• Est. primary completion date: May 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Motus GI Medical Technologies Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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