Clinical trial · Interventional
Volumetric Laser Endomicroscopy With Intelligent Real-time Image Segmentation (IRIS)
Volumetric Laser Endomicroscopy With Intelligent Real-time Image Segmentation (IRIS): a Multi-center Randomized Prospective Study
NCT03814824CI-TRIAL-00061308completedN/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)
This is a prospective randomized clinical trial examining how IRIS (Intelligent Real-time Image Segmentation) affects biopsy patterns in VLE (Volumetric laser endomicroscopy).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus With Dysplasia | — | UNRESOLVED | — |
| Barrett's Esophagus With High Grade Dysplasia | — | UNRESOLVED | — |
| Barrett's Esophagus With Low Grade Dysplasia | — | UNRESOLVED | — |
| Barrett's Esophagus Without Dysplasia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IRIS (Intelligent real-time image segmentation) | Diagnostic Test | — | UNRESOLVED |
| VLE (Volumetric laser endomicroscopy) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- VLE without IRIS, followed by VLE with IRIS
- description
- VLE (Volumetric laser endomicroscopy) performed alone, followed by IRIS (Intelligent real-time image segmentation) imaging.
- interventionNames
- Diagnostic Test: IRIS (Intelligent real-time image segmentation)
- Diagnostic Test: VLE (Volumetric laser endomicroscopy)
- type
- ACTIVE_COMPARATOR
- label
- VLE with IRIS, followed by VLE without IRIS
- description
- VLE (Volumetric laser endomicroscopy) performed with IRIS (Intelligent real-time image segmentation) imaging, followed by VLE alone.
- interventionNames
- Diagnostic Test: IRIS (Intelligent real-time image segmentation)
- Diagnostic Test: VLE (Volumetric laser endomicroscopy)
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older at the time of informed consent * Barrett's esophagus greater than 2 cm in length * Undergoing a scheduled upper endoscopy with VLE exam for surveillance as standard of care Exclusion Criteria: * Less than 18 years old at the time of informed consent * Unable to provide written informed consent * Esophageal stenosis/stricture preventing VLE * Esophagitis * Severe medical comorbidities preventing endoscopy * Pregnancy * Uncontrolled coagulopathy
References
Publications (27)
- BACKGROUNDShaheen NJ, Falk GW, Iyer PG, Gerson LB; American College of Gastroenterology. ACG Clinical Guideline: Diagnosis and Management of Barrett's Esophagus. Am J Gastroenterol. 2016 Jan;111(1):30-50; quiz 51. doi: 10.1038/ajg.2015.322. Epub 2015 Nov 3. PMID 26526079
- BACKGROUNDSpechler SJ, Souza RF. Barrett's esophagus. N Engl J Med. 2014 Aug 28;371(9):836-45. doi: 10.1056/NEJMra1314704. No abstract available. PMID 25162890
- BACKGROUNDPohl H, Welch HG. The role of overdiagnosis and reclassification in the marked increase of esophageal adenocarcinoma incidence. J Natl Cancer Inst. 2005 Jan 19;97(2):142-6. doi: 10.1093/jnci/dji024. PMID 15657344
- BACKGROUNDBhat SK, McManus DT, Coleman HG, Johnston BT, Cardwell CR, McMenamin U, Bannon F, Hicks B, Kennedy G, Gavin AT, Murray LJ. Oesophageal adenocarcinoma and prior diagnosis of Barrett's oesophagus: a population-based study. Gut. 2015 Jan;64(1):20-5. doi: 10.1136/gutjnl-2013-305506. Epub 2014 Apr 3. PMID 24700439
- BACKGROUNDCorley DA, Mehtani K, Quesenberry C, Zhao W, de Boer J, Weiss NS. Impact of endoscopic surveillance on mortality from Barrett's esophagus-associated esophageal adenocarcinomas. Gastroenterology. 2013 Aug;145(2):312-9.e1. doi: 10.1053/j.gastro.2013.05.004. Epub 2013 May 11. PMID 23673354
- BACKGROUNDLevine DS, Haggitt RC, Blount PL, Rabinovitch PS, Rusch VW, Reid BJ. An endoscopic biopsy protocol can differentiate high-grade dysplasia from early adenocarcinoma in Barrett's esophagus. Gastroenterology. 1993 Jul;105(1):40-50. doi: 10.1016/0016-5085(93)90008-z. PMID 8514061
- BACKGROUNDJankowski M, Wani S. Diagnostic and Management Implications of Basic Science Advances in Barrett's Esophagus. Curr Treat Options Gastroenterol. 2015 Mar;13(1):16-29. doi: 10.1007/s11938-014-0040-9.