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OpenTrials
Completed

NCT Number: NCT02161536

Evaluation of the Performance of the Motus Cleansing System

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

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Key information

Conditions

Colonoscopy Procedure

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motus Cleansing System

Device

Other names: Motus CleanC

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Motus GI Medical Technologies Ltd

Industry

Registry information

Acronym: MSC

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jun 11, 2014
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.