Evaluation of the Performance of the Motus Cleansing System
Not Applicable
Completed
- Conditions
- Colonoscopy Procedure
- Interventions
- Device: Motus Cleansing System
- Registration Number
- NCT02161536
- Lead Sponsor
- Motus GI Medical Technologies Ltd
- Brief Summary
The purpose of this study is evaluate the Motus GI Colon Cleansing system performance.
- Detailed Description
Subjects indicate for colonoscopy procedure undergo a limited bowel preparation including 20 mg Bisacodyl (4\*4 tables of 5 mg each) in split dose undergo standard colonoscopy with MCS.
following the procedure 2 follow-up call were conducted at 48 hours and 14 days after to the procedure.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
Inclusion Criteria
- Subjects in the age range of 18-75 years
- Subjects with BMI within the range of 18.5-35
- Subject is willing to sign informed consent form
Exclusion Criteria
- Active or severe IBD
- Subjects with severe diverticulitis \ diverticular disease (known or detected)
- Known or detected colonic stenosis
- Known or detected bowel obstruction
- History of prior colon surgery
- ASA≥IV (sever systemic disease)
- Sever Renal insufficiency
- Sever Liver insufficiency
- Contraindication for "colonoscopy" anesthesia \ sedation \ prep agent pregnancy
- Subjects with altered mental status/inability to provide informed consent
- Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Motus CleanC System Motus Cleansing System Colonoscopy with Motus CleanC Syetem - Device Rev 2.0 ,enrolled under protocol Rev 3.0 Motus Cleansing System Rev 2.5 Motus Cleansing System Colonoscopy with MCS Rev 2.5,enrolled under protocol Rev 4.0 Motus Cleansing System Rev 3.0 Motus Cleansing System Colonoscopy with MCS Rev 3.0,enrolled under protocol Rev 5.0
- Primary Outcome Measures
Name Time Method The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem Following the colonoscopic procedure- Up to 24 hours. The number of subjects had adequate bowel preparation after the use of Motus Cleansing System (i.e., all colon segments have BBPS\>=2) .
Each colon segment was graded by using the Boston Bowel Preparation Score index before ( at baseline) and after the cleansing of the bowel by using the Motus Cleansing System.
- Secondary Outcome Measures
Name Time Method