Clinical trial · Interventional
Randomized Controlled Study Comparing Colon Evaluation With The Pure-Vu System To A Standard Colonoscopy In Patients Who Are High Risk For Inadequate Bowel Preparation
NCT04285008CI-TRIAL-00045672RESCuewithdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor has terminated study due to COVID-19 related concerns
Summary
Brief summary (as posted)
The primary objective of this multi-center, prospective, randomized controlled trial is to evaluate the bowel cleansing after Pure-Vu use in outpatient subjects at high risk for inadequate colon preparation as compare to standard of care.
Conditions
Conditions (2)
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 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastrointestinal Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pure-Vu System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- standard Colonoscopy
- description
- Control arm Colonoscopy procedure using standard flushing and suctioning - standard of care
- type
- OTHER
- label
- Pure-Vu System
- description
- Intervention - Colonoscopy procedure using Pure-Vu System
- interventionNames
- Device: Pure-Vu System
Primary outcomes (1)
- measure
- rate of adequate cleansing level after using the Pure-Vu System as compare to sandard of care colonoscopy procedure
- timeFrame
- Up to 2 hours
- description
- A comparison between the two study arms (i.e., Pure-Vu vs. standard colonoscopy) of the rate of overall cleansing as well as cleansing per segment will be evaluated by the BBPS scoring index (Bowel preparation adequacy defined as BBPS \>2 in each segment)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults \> age 22 2. Elective outpatient colonoscopy by participating gastroenterologist 3. Stool clarity grade 1-3 at presentation for colonoscopy Exclusion Criteria: 1. Not competent to consent 2. Bleeding disorder - known or suspected 3. Hereditary Gastrointestinal Cancer syndrome 4. Known PT INR \> 1.5 5. Know elevated PTT 6. Anti-platelet agent or anticoagulant (other than aspirin or nonsteroidal agent) which has not been stopped for the colonoscopy 7. Known platelet count \< 50,000 8. Known absolute neutrophil count \< 1,000 9. History of surgical colon resection 10. Pre-colonoscopy intent to enter terminal ileum 11. Prior incomplete colonoscopy due to technical \& non-bowel preparation related reasons 12. Regular use of non-topical steroid 13. Pregnant 14. Prisoner or institutionalized for any reason 15. Psychiatric illness greater than mild 16. Colonoscopy without anesthesia administered (MAC) sedation 17. Diverticulitis 18. Active inflammatory bowel disease (Crohn's, Ulcerative Colitis, or Indeterminate) 19. Known or suspected colon stricture
References
Publications (0)
Data not yet available
No reference posted for this study.