Clinical trial · Observational
Optivista : I-SCAN OE for Optical Diagnosis of Small Colon Polyps
- 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)
This prospective randomized clinical trial aims to evaluate the new Optivista system compared to the iScan for his optical diagnosis and interval agreement monitoring with pathology. The Participants will be randomized to be diagnosed by either Optivista or Pentax iScan, and all polyps detected during the procedure, their size, location and morphology will be recorded according to the Paris classification after which all polyps will be resected per standard practices and sent for histopathologic evaluation. Further optical assessments will be performed for all polyps of 1-10 mm in size (WASP, NICE, SANO and SIMPLE classification) after with an analysis of comparison between optical diagnosis and pathology results will be performed.
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 |
|---|---|---|---|
| Colo-rectal Cancer | — | UNRESOLVED | — |
| Polyps of Colon | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Screening colonoscopy according to resect-and-discard strategy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Optical diagnosis with Optivista
- description
- Participants for which the optical diagnosis of detected colorectal polyps will be done with the new technique Pentax Optivista.
- interventionNames
- Diagnostic Test: Screening colonoscopy according to resect-and-discard strategy
- label
- Optical diagnosis with iScan
- description
- Participants for which the optical diagnosis of detected colorectal polyps will be done with the oldest technique Pentax iScan.
- interventionNames
- Diagnostic Test: Screening colonoscopy according to resect-and-discard strategy
Primary outcomes (2)
- measure
- Concordance of Optical diagnosis with the pathology based reference standard
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Aged 45 to 80 years * Indication for full colonoscopy Exclusion Criteria: * Known inflammatory bowel disease * Active colitis * Coagulopathy * Familial polyposis syndrome * Poor general health defined as an ASA class \> 3 * Emergency colonoscopies
References
Publications (1)
- DERIVEDDjinbachian R, Marchand E, Pohl H, Aguilera-Fish A, Bouin M, Deslandres E, Weber A, Bouchard S, Panzini B, von Renteln D. Optical diagnosis of colorectal polyps: a randomized controlled trial comparing endoscopic image-enhancing modalities. Gastrointest Endosc. 2021 Mar;93(3):712-719.e1. doi: 10.1016/j.gie.2020.11.023. Epub 2020 Dec 2. PMID 33275913