Evaluation of the Performance of the Motus Cleansing System

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Colonoscopy Procedure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Bowel cleansing level was evaluated by using the Boston Bowel Preparation Score (BBPS) at baseline and after the use of the Motus Cleansing System.

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Motus CleanC System

Colonoscopy with Motus CleanC Syetem - Device Rev 2.0 ,enrolled under protocol Rev 3.0

Group Type EXPERIMENTAL

Motus Cleansing System

Intervention Type DEVICE

Motus Cleansing System Rev 2.5

Colonoscopy with MCS Rev 2.5,enrolled under protocol Rev 4.0

Group Type EXPERIMENTAL

Motus Cleansing System

Intervention Type DEVICE

Motus Cleansing System Rev 3.0

Colonoscopy with MCS Rev 3.0,enrolled under protocol Rev 5.0

Group Type EXPERIMENTAL

Motus Cleansing System

Intervention Type DEVICE

Interventions

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Motus Cleansing System

Intervention Type DEVICE

Other Intervention Names

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Motus CleanC

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes