Evaluation of the Performance of the Motus Cleansing System

Colonoscopy Procedure Clinical Trial

— MSC  

Official title:

Evaluation of the Performance of the Motus Cleansing System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161536
• Other study ID #: CP-MCC-SA-0214
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Motus GI Medical Technologies Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy Procedure

Intervention

Device:
• Motus Cleansing System

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Motus GI Medical Technologies Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.