Evaluation of the Performance of the Motus Cleansing System (MSC)

Motus GI

Status: Completed

Conditions: Colonoscopy Procedure

Treatments: Device: Motus Cleansing System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02161536

CP-MCC-SA-0214

Details and patient eligibility

About

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

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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47 participants in 3 patient groups

Motus CleanC System

Experimental group

Description:

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

Treatment:

Device: Motus Cleansing System

Motus Cleansing System Rev 2.5

Experimental group

Description:

Colonoscopy with MCS Rev 2.5,enrolled under protocol Rev 4.0

Treatment:

Device: Motus Cleansing System

Motus Cleansing System Rev 3.0

Experimental group

Description:

Colonoscopy with MCS Rev 3.0,enrolled under protocol Rev 5.0

Treatment:

Device: Motus Cleansing System