Clinical trial · Interventional
Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial
NCT01370928CI-TRIAL-00006800completedPhase 3ClinicalTrials.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 purpose of this study is to compare the performance of a new prototype colonoscope with a standard colonoscope used world-wide today. The prototype colonoscope is more flaccid with a smaller diameter than the standard colonoscope. The hypothesis to be tested is that the prototype will improve negotiation of sharp bends and inflict less discomfort or pain to the patient. Both colonoscopes are manufactured by the same company.
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 |
|---|---|---|---|
| Adenomas | Adenoma | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Olympus PCF-Y0014-L | Device | — | UNRESOLVED |
| Standard colonoscope | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prototype colonoscope
- description
- The new colonoscope to be tested
- interventionNames
- Device: Olympus PCF-Y0014-L
- type
- ACTIVE_COMPARATOR
- label
- Standard colonoscope
- description
- The standard colonoscope used world-wide today.
- interventionNames
- Device: Standard colonoscope
Primary outcomes (1)
- measure
- Patients´ evaluation of pain and discomfort
- timeFrame
- 24 hours
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 54 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Persons included in the NordICC trial are eligible for inclusion * For information about the NordICC trial see clinicaltrials.gov NCT00883792 Exclusion Criteria: * Pregnancy * Persons younger than 18 years * Persons unable to comprehend the information given * not possible to start the examination without prior administration of sedation/analgesics
References
Publications (1)
- DERIVEDGarborg KK, Loberg M, Matre J, Holme O, Kalager M, Hoff G, Bretthauer M. Reduced pain during screening colonoscopy with an ultrathin colonoscope: a randomized controlled trial. Endoscopy. 2012 Aug;44(8):740-6. doi: 10.1055/s-0032-1309755. Epub 2012 May 23. PMID 22622786