N/A
N=15
Evaluation of the Motus GI CleanUp System During Screening Colonoscopy
CRC
Bottom Line
View on ClinicalTrials.gov: NCT01838980 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Mean of All Subjects Colon Segments BBPS>=2 — 3 Mean of BBPS score per segment
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Motus GI Clean-Up Device (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Motus GI Medical Technologies Ltd
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean of All Subjects Colon Segments BBPS>=2 |
3 | — |
Summary
Motus GI is developing a single-use device that attaches to a standard colonoscope, thereby integrating colon cleansing, screening and treatment into one procedure. The device creates turbulence within the colon using water jets. The colon's fecal fluids are evacuated by the system.
Eligibility Criteria
Inclusion Criteria
- Subjects in the age range of 50-69 years
- Subjects who are considered for routine screening colonoscopy
- Subjects with BMI within the range of 18.5-30
- Subject is willing to sign informed consent form
Exclusion Criteria
- History of GI diseases or history of Colorectal cancer (personal or family)
- Previous major abdominal surgeries
- Medical status ASA grater or equal to 3
- Acute GI symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (IBD).
- Patients taking anticoagulants (e.g., Coumadin, Heparin, Clopidrogrel)
- Life-threatening condition
- Subjects who are unable or unwilling to cooperate with study procedures
- Severe Diverticula
Data sourced from ClinicalTrials.gov (NCT01838980). 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.