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

NCT ID: NCT03922906

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-21
• Study Completion Date: 2021-02-02

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.

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.

Conditions

CRC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pure-Vu System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Motus GI Medical Technologies Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Countries

Israel

Other Identifiers

CL00046

Identifier Type: -

Identifier Source: org_study_id