Evaluation of the Performance of the Motus Cleansing System

Study Overview
=================
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.

Official Title
-----------------
Evaluation of the Performance of the Motus Cleansing System

Conditions
-----------------
Colonoscopy Procedure

Intervention / Treatment
-----------------
* Device: Motus Cleansing System


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Bowel cleansing level was evaluated by using the Boston Bowel Preparation Score (BBPS) at baseline and after the use of the Motus Cleansing System.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motus CleanC System<br>Colonoscopy with Motus CleanC Syetem - Device Rev 2.0 ,enrolled under protocol Rev 3.0 | Device: Motus Cleansing System<br> <br> * Other names: Motus CleanC;|
| Experimental: Motus Cleansing System Rev 2.5<br>Colonoscopy with MCS Rev 2.5,enrolled under protocol Rev 4.0 | Device: Motus Cleansing System<br> <br> * Other names: Motus CleanC;|
| Experimental: Motus Cleansing System Rev 3.0<br>Colonoscopy with MCS Rev 3.0,enrolled under protocol Rev 5.0 | Device: Motus Cleansing System<br> <br> * Other names: Motus CleanC;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem | 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. | Following the colonoscopic procedure- Up to 24 hours. |