Clinical trial · Interventional
Staging of Superficial EAC Using VLE
Staging of Superficial Esophageal Adenocarcinoma (EAC) Using Volumetric Laser Endomicroscopy (VLE)
NCT03385343CI-TRIAL-00066238terminatedN/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): Device company went out of business
Summary
Brief summary (as posted)
This study is being done to see if the NvisionVLE Imaging System can accurately determine the diagnostic performance of staging of T1 esophageal adenocarcinoma.
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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VLE imaging for staging EAC | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VLE imaging of stage EAC
- description
- All subjects will receive VLE imaging for staging EAC. Volumetric laser endomicroscopy (VLE) is an imaging platform that uses infrared light to generate cross-sectional views of the human esophagus with microscopic resolution.
- interventionNames
- Diagnostic Test: VLE imaging for staging EAC
Primary outcomes (2)
- measure
- Percentage of Subjects Whose VLE Results Correlates With the Histology Results for T1 EAC Depth of Invasion
- timeFrame
- 1 day
- description
- A validated computer algorithm will be used to quantify the degree of signal attenuation in the T1 EAC endoscopic mucosal resection specimen database. Volumetric Laser Endo-microscopy (VLE) signal attenuation measurements will be correlated to depth of invasion as determined by histology.
- measure
- Percentage of Subjects Whose VLE Results Correlates With the Histology Results for Staging T1 EAC
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * Patient over the age of 18 * 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 who have achieved complete remission of intestinal metaplasia (CR-IM) * Patients without visible Barrett's Esophagus at the time of study esophagogastroduodenoscopy (EGD) * 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 anticoagulation 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.