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

CRC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03922906
• Other study ID #: CL00046
• Status: Terminated
• Phase: N/A
• Start date: January 21, 2020
• Est. completion date: February 2, 2021

Study information

• Verified date: February 2021
• Source: Motus GI Medical Technologies Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 2, 2021
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• CRC

Intervention

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.

Locations

Country	Name	City	State
Israel	Chaim Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Motus GI Medical Technologies Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of Pure-Vu System	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	Up to 2 hours