CRC
Conditions
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.
Interventions
DEVICEPure-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.
Sponsors
Motus GI Medical Technologies Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of Pure-Vu System | Up to 2 hours | 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 |
Countries
Israel
Outcome results
None listed