Evaluation of the Performance of the Motus Cleansing System

Motus GI Medical Technologies Ltd47 enrolled

Overview

The purpose of this study is evaluate the Motus GI Colon Cleansing system performance.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Colonoscopy Procedure

Interventions

Motus Cleansing SystemDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Following the colonoscopic procedure- Up to 24 hours.

Data from ClinicalTrials.gov

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