Clinical trial · Interventional
ColoAssist vs. MEI
ColoAssist vs. Magnetic Guided Colonoscopy - a Randomized Controlled Trial
- 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)
Colonoscopy aims to investigate the entire colon by advancing the colonoscope tip from the rectum to the cecum, a process called cecal intubation. Cecal intubation may be difficult for different reasons, and features of the colonoscope and the use of imaging devices may influence the success rate. We want to compare the performance of a new colonoscope with novel features including gradual stiffness with that of a colonoscope supplied with a magnetic endoscope imaging (MEI) device. The hypothesis is that the performance of the new instrument is non-inferior to the MEI system.
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 |
| Screening | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ColoAssist | Device | — | UNRESOLVED |
| MEI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ColoAssist
- description
- Screening colonoscopy with a new colonoscope with gradual stiffness
- interventionNames
- Device: ColoAssist
- type
- ACTIVE_COMPARATOR
- label
- MEI
- description
- Screening colonoscopy with colonoscopes compatible with and guided by MEI
- interventionNames
- Device: MEI
Primary outcomes (1)
- measure
- Cecal intubation rate
- timeFrame
- 1 hour
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 66 Years
Show eligibility criteria text
Inclusion Criteria: * Inclusion in an ongoing colorectal cancer screening trial (NCT 00883792) Exclusion Criteria: * Excluded from the ongoing screening trial (NCT 00883792) * Inability or unwilling to provide informed consent
References
Publications (1)
- DERIVEDGarborg K, Wiig H, Hasund A, Matre J, Holme O, Noraberg G, Loberg M, Kalager M, Adami HO, Bretthauer M. Gradual stiffness versus magnetic imaging-guided variable stiffness colonoscopes: A randomized noninferiority trial. United European Gastroenterol J. 2017 Feb;5(1):128-133. doi: 10.1177/2050640616639162. Epub 2016 Jun 23. PMID 28405331