Clinical trial NCT03922906: Evaluation of Bowel Cleansing Using the Pure-Vu System in Patients With History of Inadequate Bowel Preparation
Official title: Evaluation of Bowel Cleansing Using the Pure-Vu System in Patients With History of Inadequate Bowel Preparation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: CRC
Lead sponsor: Motus GI Medical Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2019-04-22
Enrollment: 3
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of Pure-Vu System
timeFrame: Up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
References: