Clinical trial NCT03493009: Optimizing the Preparation Regime Prior to Colonoscopy Procedure With Pure-Vu System
Official title: Optimizing the Preparation Regime Prior to Colonoscopy Procedure With Pure-Vu System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastrointestinal Diseases
Colorectal Cancer
Lead sponsor: Motus GI Medical Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2018-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization in blocks will be applied for each site to allocate patients to one of two different bowel preparation regimens (Prep A- split doae of 10mg of Magnesium citrate versus Prep B- split doae of 15mg of Magnesium citrate). The study will utilize randomization in blocks using the standard envelope procedure, which will be applied in order to allocate patients into two arms:

* Group 1 - Will go through the Prep A procedure
* Group 2 - Will go through the Prep B procedure The site randomization plan will be provided to the study coordinator prior the study start.
Primary purpose: SCREENING

Brief summary: The primary objective of this multicenter, prospective, randomized study is to evaluate the performance of Pure-Vu System in cleansing patients' colon who are indicated for a colonoscopy procedure using one of two different reduce bowel preparation regimes.in addition, the cecum intubation rate, time to cecum, total procedure time, and adverse event will be evaluated.

Detailed description: This multicenter, prospective, randomized study will include up to 100 patients (30 patients per site and 15 patients per study arm), aimed at evaluating the performance of Pure-Vu System in cleansing patients' colon who are indicated for colonoscopy procedure using one of two different preparation regimes as detailed below.

Subjects will be enrolled at up to 10 clinical sites in the United States. Subjects who meet the eligibility criteria will be randomly allocated to a given study arm and will be required to follow a specific bowel preparation instruction along with a specific prep agent (Bowel preparation instructions for morning and afternoon procedures are provided in appendix B1 and B2, respectively), as per study arm allocation, starting 5 days prior to the colonoscopy with Pure-Vu. 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 D).

In addition patient will be ask 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 scheduled for colonoscopy procedure
2. Subjects in the age range of 22-75 years inclusive
3. Subject is willing and able to participate in the study procedures and to understand and sign the informed consent.

Exclusion Criteria:

1. Patients with active Inflammatory Bowel Disease
2. Patients with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
3. Patients with known bowel obstruction
4. Patient with chronic constipation
5. History of prior surgery to colon and/or rectum
6. ASA (Physical status classification system) ≥ III
7. Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)
8. Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)
9. Patients taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy
10. Patients with known coagulation disorder (INR \>1.5).
11. Pregnancy (as stated by patient) or breast feeding
12. Patients with altered mental status/inability to provide informed consent

Primary outcomes:
measure: rate of adequate cleansing level
timeFrame: up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: