Clinical trial · Interventional
Evaluation of the Performance of the CleanC System-Israel
Evaluation of the Performance of the "CleanC" System
NCT02387268CI-TRIAL-00029618completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (CRC) Screening | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CleanC system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CleanC
- description
- Standard colonoscopy procedure using the CleanC system
- interventionNames
- Device: CleanC system
Primary outcomes (2)
- measure
- Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )
- timeFrame
- During the colonoscopy procedure withdrawal phase (10 min in average)
- description
- Scale ranges- Min-0, Max-3 where: 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. 1. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid. 2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well. 3. = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects in the age range of 18-75 years 2. Subjects with BMI within the range of 18.5-35 3. Subject is willing to sign informed consent form Exclusion Criteria: 1. Active or severe inflammatory bowel disease (IBD) 2. Subjects with severe diverticulitis \\ diverticular disease (known or detected) 3. Known or detected colonic stenosis 4. Known or detected bowel obstruction 5. History of prior colon surgery 6. ASA≥IV (sever systemic disease) 7. Sever Renal insufficiency (Creatinine≥1.5mg%) 8. Sever Liver insufficiency (ALT/AST≥2UNL) 9. Contraindication for "colonoscopy" anesthesia \\ sedation \\ prep agent 10. pregnancy 11. Subjects with altered mental status/inability to provide informed consent 12. 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
References
Publications (0)
Data not yet available
No reference posted for this study.