Evaluation of the Performance of the Motus Cleansing System

NCT02161536 | Completed Results

• 1 other identifier: CP-MCC-SA-0214
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Colonoscopy Procedure

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

Motus CleanC System

EXPERIMENTAL

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

Device: Motus Cleansing System

Motus Cleansing System Rev 2.5

EXPERIMENTAL

Colonoscopy with MCS Rev 2.5,enrolled under protocol Rev 4.0

Device: Motus Cleansing System

Motus Cleansing System Rev 3.0

EXPERIMENTAL

Colonoscopy with MCS Rev 3.0,enrolled under protocol Rev 5.0

Device: Motus Cleansing System

Interventions

Motus Cleansing System DEVICE

Also known as: Motus CleanC

Motus CleanC System; Motus Cleansing System Rev 2.5; Motus Cleansing System Rev 3.0

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Motus GI Medical Technologies Ltd: lead

Results Point of Contact

• Title: Ravit Peled -Director of Clinical Trial
• Organization: Motus GI Medical Technologies Ltd.

ravit@motusgi.com

+972 526145354

Study Officials

• Ravit Peled

  Motus GI Technologies Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 11, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: March 1, 2017
• Last Updated: November 6, 2018
• Results First Posted: November 6, 2018

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share