Clinical trial · Interventional
Trial on Innovative Technologies in Colonoscopy
Prospective Randomised Trial Comparing New Technologies of Endoscopic Bowel Visualisation With Conventional Colonoscopy.
- 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 trial will compare results of screening colonoscopy performed by means of conventional colonoscopy and using new visualisation techniques during endoscopic examination. * Electronic colonoscopes Olympus CF-HQ190F with following options: magnetic positioning (Scope Guide), responsive insertion technology (RIT), dual focus function, narrow band imaging (NBI) will be used for innovative colonoscopies * Electronic colonoscopes Olympus CF-H180DL with Scope Guide and NBI options will be used for conventional colonoscopies Endoscopists will archive all images and establish presumptive diagnosis based on the results of different visualisation techniques. All endoscopes will be attached to Olympus Evis Exera III system. Biopsy of all pathological lesions will be performed to establish final diagnosis. The main outcome measure is diagnostic accuracy of innovative colonoscopy in comparison with conventional technique.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Inflammatory Bowel Disease | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Polyps | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional colonoscopy (Olympus CF-H180DL) | Device | — | UNRESOLVED |
| Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Innovative colonoscopy
- description
- Innovative colonoscopy performed using narrow band imaging and dual focus function (NBI + Dual Focus).
- interventionNames
- Device: Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus)
- type
- ACTIVE_COMPARATOR
- label
- Conventional colonoscopy
- description
- Conventional colonoscopy performed without innovative techniques assessed in this study.
- interventionNames
- Device: Conventional colonoscopy (Olympus CF-H180DL)
Primary outcomes (1)
- measure
- Diagnostic accuracy of innovative colonoscopy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * written informed consent * no previous abdominal surgery * no colonoscopy during last 10 years Exclusion Criteria: * age \< 40 and \> 65 years * large bowel resection in history * colonoscopy performed during last 10 years * contraindications for general anaesthesia * ASA \> IV * pregnancy * confirmed neoplastic disease * cirrhosis (Child B or C) or ascites * immunosuppressive therapy or steroids intake * malabsorption syndrome
References
Publications (3)
- RESULTSzura M, Pasternak A, Bucki K, Urbanczyk K, Matyja A. Two-stage optical system for colorectal polyp assessments. Surg Endosc. 2016 Jan;30(1):204-14. doi: 10.1007/s00464-015-4186-x. Epub 2015 Apr 4. PMID 25840894
- DERIVEDPasternak A, Szura M, Solecki R, Matyja M, Szczepanik A, Matyja A. Impact of responsive insertion technology (RIT) on reducing discomfort during colonoscopy: randomized clinical trial. Surg Endosc. 2017 May;31(5):2247-2254. doi: 10.1007/s00464-016-5226-x. Epub 2016 Sep 8. PMID 27631316
- DERIVEDSzura M, Pasternak A, Solecki R, Matyja M, Szczepanik A, Matyja A. Accuracy of preoperative tumor localization in large bowel using 3D magnetic endoscopic imaging: randomized clinical trial. Surg Endosc. 2017 May;31(5):2089-2095. doi: 10.1007/s00464-016-5203-4. Epub 2016 Aug 29. PMID 27572063