Clinical trial · Interventional
Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia
The Use of Volumetric Laser Endomicroscopy to Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia
NCT03670134CI-TRIAL-00057463withdrawnN/AClinicalTrials.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): The company that supported the technology (volumetric laser endomicroscopy) is no longer operational due to the pandemic.
Summary
Brief summary (as posted)
Researchers are trying to see if the Nvision® Imaging System (VLE) can accurately determine the risk of recurrent Barrett's esophagus in patients with Barrett's esophagus which have been clear of disease.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The Nvision VLE Imaging System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Volumetric laser Endomicroscopy (VLE)
- description
- Volumetric laser Endomicroscopy (VLE) is a second-generation optical coherence tomography platform that can image the human esophagus in cross-section at microscopic resolution this will performed by using the Nvision VLE Imaging System.
- interventionNames
- Device: The Nvision VLE Imaging System
Primary outcomes (3)
- measure
- Determine association between number of glandular structures measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy
- timeFrame
- 1 year
- description
- Measure the number of glandular structures observed with volumetric laser endomicroscopy in patients who remain free of Barrett's esophagus and in those with recurrent disease. Report the mean and standard-deviation of this metric and determine a statistical significant difference using the Student's t-test.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient undergoing an upper endoscopy with prior biopsy confirmed Barrett's Esophagus. * Ability to provide written, informed consent * No significant esophagitis (LA grade \<B, C, and D) Exclusion Criteria: * Patients for whom use of the NvisionVLE device would be in conflict with the instruction for use. * Prior esophageal or gastric surgical resection * Significant esophageal stricture requiring dilatation * Patients who require anti-coagulation for who biopsy would be contraindicated * Patients who are known to be pregnant
References
Publications (0)
Data not yet available
No reference posted for this study.