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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02161536
Recruitment Status : Completed
First Posted : June 11, 2014
Results First Posted : November 6, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Motus GI Medical Technologies Ltd

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

Condition or disease Intervention/treatment Phase
Colonoscopy Procedure Device: Motus Cleansing System Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Bowel cleansing level was evaluated by using the Boston Bowel Preparation Score (BBPS) at baseline and after the use of the Motus Cleansing System.
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of the Performance of the Motus Cleansing System
Actual Study Start Date : July 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : March 2017

Arm Intervention/treatment
Experimental: Motus CleanC System
Colonoscopy with Motus CleanC Syetem - Device Rev 2.0 ,enrolled under protocol Rev 3.0
Device: Motus Cleansing System
Other Name: Motus CleanC

Experimental: Motus Cleansing System Rev 2.5
Colonoscopy with MCS Rev 2.5,enrolled under protocol Rev 4.0
Device: Motus Cleansing System
Other Name: Motus CleanC

Experimental: Motus Cleansing System Rev 3.0
Colonoscopy with MCS Rev 3.0,enrolled under protocol Rev 5.0
Device: Motus Cleansing System
Other Name: Motus CleanC




Primary Outcome Measures :
  1. The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem [ Time Frame: Following the colonoscopic procedure- Up to 24 hours. ]

    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.




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161536


Sponsors and Collaborators
Motus GI Medical Technologies Ltd
Investigators
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Study Director: Ravit Peled Motus GI Technologies Ltd.
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Responsible Party: Motus GI Medical Technologies Ltd
ClinicalTrials.gov Identifier: NCT02161536    
Other Study ID Numbers: CP-MCC-SA-0214
First Posted: June 11, 2014    Key Record Dates
Results First Posted: November 6, 2018
Last Update Posted: November 6, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No