Clinical trial · Interventional
The Efficacy and Patient Tolerance of Ultrathin Nasal Endoscopy to Detect Barrett's Oesophagus
Study to Compare the Efficacy and Patient Tolerance of Ultrathin Nasal Endoscopy to Detect Barrett's Esophagus Compared With Conventional Endoscopy to Inform a Future Multicentre Screening Trial
- 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 study evaluates the diagnostic accuracy, safety and acceptability of transnasal endoscopy (TNE) for a diagnosis of Barrett's esophagus (BE). This is a cross-over randomised trial, whereby patients receive two endoscopic procedures 2-4 weeks apart and will be randomised to receive either TNE or standard endoscopy followed by the other procedure.
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 |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
| Dyspepsia | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Esophageal biopsies | Procedure | — | UNRESOLVED |
| Office-based disposable transnasal endoscopy Endosheath | Device | — | UNRESOLVED |
| Standard upper GI endoscopy | Device | — | UNRESOLVED |
| Transnasal Endoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Transnasal Endoscopy
- description
- Unsedated transnasal endoscopy with biopsies
- interventionNames
- Procedure: Transnasal Endoscopy
- Device: Office-based disposable transnasal endoscopy Endosheath
- Procedure: Esophageal biopsies
- type
- ACTIVE_COMPARATOR
- label
- Standard Gastroscopy
- description
- Standard endoscopy with biopsies. Patients will decide whether they prefer to have endoscopy with intrevenous sedation or with local anaesthetic only
- interventionNames
- Device: Standard upper GI endoscopy
- Procedure: Esophageal biopsies
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: \> 18 years and \<75 years 2. Patients who have given informed consent and who are capable of filling in the questionnaire. 3. Patients requiring endoscopy for dyspepsia or follow-up evaluation and patients with a prior diagnosis of BE (defined as minimum Barrett's length of 2cm - according to M level of Prague C \& M classification) with specialized intestinal metaplasia on histological confirmation. Exclusion Criteria: 1. Previous upper GI tract or upper respiratory tract surgery or known upper GI tract abnormality (e.g. pharyngeal pouch). 2. Coagulopathy or on anticoagulants 3. Active or severe cardiopulmonary disease or liver disease 4. Active GI bleeding 5. Patients with alarm symptoms referred to the fast track service and any patient with dysphagia 6. Patients requiring possible endoscopic therapy 7. Patients with high-grade dysplasia or intramucosal carcinoma in BE requiring extensive evaluation and biopsy
References
Publications (0)
Data not yet available