Clinical trial · Interventional
Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus
NCT01288612CI-TRIAL-00016532challengecompletedN/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)
The hypothesis of this study was that the comparative effectiveness of unsedated transnasal endoscopy (uTNE) will be greater than sedated endoscopy (sEGD) in population screening for BE.
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's Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sedated Endoscopy | Device | — | UNRESOLVED |
| Transnasal Endoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Sedated Endoscopy
- description
- Sedated esophagogastroduodenoscopy with biopsy
- interventionNames
- Device: Sedated Endoscopy
- type
- ACTIVE_COMPARATOR
- label
- Transnasal Endoscopy at Hospital Unit
- description
- Unsedated transnasal endoscopy at hospital unit.
- interventionNames
- Device: Transnasal Endoscopy
- type
- ACTIVE_COMPARATOR
- label
- Transnasal Endoscopy at Mobile Unit
- description
- Unsedated transnasal endoscopy in mobile research van
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * Olmsted county, Minnesota resident * Age 50 or older * Able to give informed consent Exclusion Criteria: * History of known Barretts Esophagus (BE) or endoscopy within the last 10 years * History of progressive dysphagia * Known Zenkers or epiphrenic diverticulum * History of recurrent epistaxis * Illnesses that impair ability to complete questionnaires (e.g. metastatic cancer, stroke, dementia) * Contraindication to esophageal biopsy (such as anticoagulation using warfarin or clopidogrel).
References
Publications (1)
- RESULTSami SS, Dunagan KT, Johnson ML, Schleck CD, Shah ND, Zinsmeister AR, Wongkeesong LM, Wang KK, Katzka DA, Ragunath K, Iyer PG. A randomized comparative effectiveness trial of novel endoscopic techniques and approaches for Barrett's esophagus screening in the community. Am J Gastroenterol. 2015 Jan;110(1):148-58. doi: 10.1038/ajg.2014.362. Epub 2014 Dec 9. PMID 25488897