Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System
- Conditions
- Gastrointestinal DiseaseColorectal Cancer
- Interventions
- Device: Pure-Vu System
- Registration Number
- NCT03503162
- Lead Sponsor
- Motus GI Medical Technologies Ltd
- Brief Summary
The aim of this study is to evaluate the potential improvement in colonoscopy procedure's outcomes when using the Pure-Vu System in hospitalized patients who are indicated for colonoscopy procedure.
- Detailed Description
This multi-center, prospective, single arm study will include up to 100 patients (20-40 patients per site), aimed at evaluating the performance of the Pure-Vu System in cleansing hospitalized patients' colon who are indicated for standard colonoscopy procedure.
Subjects will be enrolled at up to 4 clinical sites in the United States and Europe. Subjects who meet the eligibility criteria will be prescribed a standard bowel preparation bowel preparation regimen including diet restrictions and oral bowel preparation.
Following the bowel preparation, the patient will undergo colonoscopy with the Pure-Vu system.
In case of inadequate bowel preparation, as per the nurse report and / or BBPS \< 2, in at least one of the colon segments, prior Pure-Vu use, the physician will complete a questionnaire on the patient's management standard of care assuming the absence of Pure-Vu.
Follow-up will be conducted at 48 hours (± 48 hours) post procedure.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
- Hospitalized patients who are indicated for a screening, diagnostic, surveillance or therapeutic colonoscopy
- Patients' age > 22 years
- Patient has signed the informed consent
- Patients with known Inflammatory Bowel Disease and / or active Colitis
- Patients with active diverticulitis
- Patients with known or detected (during colonoscopy) bowel obstruction
- Patients with BMI ≤ 18
- Patients with ascites Child Pugh C
- Patients who are 30 days post-transplant
- Patients treated with Peritoneal dialysis
- Patients under active IV inotropic medications
- Patients with LVAD
- Patients who have active anticoagulant medications (excluding aspirin) or dual antiplatelet therapy in their system prior to the procedure. (Note: to avoid exclusion therapy should be discontinued 48 hours or greater prior to the procedure based on discretion of physician)
- Subjects with known coagulation disorder (INR ≥ 2 or platelets <50,000)
- Subjects with hemodynamic instability.
- Pregnancy (as stated by patient) or breast feeding
- Subjects with altered mental status/inability to provide informed consent
- Patients who have participated in another interventional clinical study in the last 2 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Colonoscopy with Pure-Vu System Pure-Vu System Standard colonoscopy procedure with Pure-Vu System
- Primary Outcome Measures
Name Time Method The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System up to 2 hours The rate of adequate cleansing level in each colon segment before and after use of Pure-Vu will be evaluated 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) summed for the maximum score of 9 (0= dirtiest and 9= pristine).
An adequate cleansing procedure will be considered when all the colon segments will be graded as 2 or above.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States