Clinical trial · Interventional
Cap Assisted Upper Endoscopy Versus High Definition White Light Endoscopy and Narrow Band Imaging Alone In The Detection Of Visible Lesions Barrett's Esophagus: A Randomized Tandem Study
NCT03417570CI-TRIAL-00060637terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Futility
Summary
Brief summary (as posted)
The hypothesis is that the addition of a transparent cap to the end of the endoscope will increase the detection and diagnostic yield of visible lesions in Barrett's esophagus. Thus, the goal of this tandem design trial is to compare the diagnostic yield (DY) of cap assisted endoscopy with that of conventional endoscopy using high definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI) in patients with Barrett's esophagus.
Conditions
Conditions (1)
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 Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI) | Procedure | — | UNRESOLVED |
| Olympus Disposable Distal Attachment Cap | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: EGD with cap first, followed by EGD without cap
- description
- -Participants in the first arm will undergo EGD with cap first, followed by EGD without cap in the same procedural period.
- interventionNames
- Procedure: Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI)
- Device: Olympus Disposable Distal Attachment Cap
- type
- EXPERIMENTAL
- label
- Arm 2: EGD without cap first, followed by EGD with cap
- description
- -Participants in the second arm will undergo EGD without cap first, followed by EGD with cap in the same procedural period.
- interventionNames
- Procedure: Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI)
- Device: Olympus Disposable Distal Attachment Cap
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must be at least 18 years of age. * Must be patients undergoing standard of care EGD for the confirmation of dysplasia in BE or EET for dysplasia in BE. * Must be able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria: * Pregnant or breastfeeding. * Prior endoscopic treatment for BE. * Unable to tolerate sedation due to medical comorbidities.
References
Publications (0)
Data not yet available
No reference posted for this study.