Clinical trial · Interventional
A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy
A 4-arm Randomized Controlled Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy
NCT02345889CI-TRIAL-00037549completedN/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)
Adenoma detection rate (ADR) is a validated marker for reducing the risk of interval colorectal cancer after a screening colonoscopy. Recent studies suggest that novel devices attached to the colonoscope tip may improve the ADR of doctors performing a screening procedure
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 Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy with EndoCuff™ | Device | — | UNRESOLVED |
| Colonoscopy with EndoRings™ | Device | — | UNRESOLVED |
| FUSE® Colonoscopy | Device | — | UNRESOLVED |
| Standard Colonoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- FUSE® Colonoscopy
- description
- A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
- interventionNames
- Device: FUSE® Colonoscopy
- type
- ACTIVE_COMPARATOR
- label
- Colonoscopy with EndoCuff™
- description
- An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
- interventionNames
- Device: Colonoscopy with EndoCuff™
- type
- ACTIVE_COMPARATOR
- label
- Colonoscopy with EndoRings™
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Screening or Surveillance Colonoscopy Exclusion Criteria: * Personal history of Colorectal cancer or Inflammatory bowel disease * Surgical resection of the colon or known colonic stricture * Personal or family history of Polyposis syndromes or Lynch syndrome * Referral for incomplete colonoscopy or known therapeutic polyp clearance * Severe diverticular disease * Referral for a positive hemoccult test in the past 6 months * Known coagulopathy * Inability to provide informed consent
References
Publications (1)
- DERIVEDRex DK, Repici A, Gross SA, Hassan C, Ponugoti PL, Garcia JR, Broadley HM, Thygesen JC, Sullivan AW, Tippins WW, Main SA, Eckert GJ, Vemulapalli KC. High-definition colonoscopy versus Endocuff versus EndoRings versus full-spectrum endoscopy for adenoma detection at colonoscopy: a multicenter randomized trial. Gastrointest Endosc. 2018 Aug;88(2):335-344.e2. doi: 10.1016/j.gie.2018.02.043. Epub 2018 Mar 9. PMID 29530353