N/A
N=47
Evaluation of the Performance of the Motus Cleansing System
Colonoscopy Procedure
Bottom Line
View on ClinicalTrials.gov: NCT02161536 ↗Enrolled (actual)
47
Serious AEs
2.1%
Results posted
Nov 2018
Primary outcome: Primary: The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem — 6; 20; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Motus Cleansing System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Motus GI Medical Technologies Ltd
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem |
6; 20; 20 | — |
Summary
The purpose of this study is evaluate the Motus GI Colon Cleansing system performance.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02161536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.