Clinical trial · Interventional
Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System
Identification of Features Associated With Dysplasia Using the NvisionVLE® Imaging System Pilot Trial
NCT02864043CI-TRIAL-00043791DDPunknownN/AClinicalTrials.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 NvisionVLE® Dysplasia Detection Pilot Study is a prospective, non-randomized trial for participants who have a prior biopsy-confirmed diagnosis of BE with dysplasia and are scheduled to have an endoscopic evaluation of your esophagus for BE surveillance by a standard procedure called EGD (esophagogastroduodenoscopy) as well as an imaging procedure called VLE (volumetric laser endomicroscopy).
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 |
|---|---|---|---|
| esophagogastroduodenoscopy (EGD) | Procedure | — | UNRESOLVED |
| NvisionVLE with Real Time Targeting | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- EGD with NvisionVLE with Real Time Targeting
- description
- Physician will complete a VLE scan of the esophagus and target areas of interest using the VLE optical marking probe following standard of care endoscopy
- interventionNames
- Device: NvisionVLE with Real Time Targeting
- Procedure: esophagogastroduodenoscopy (EGD)
Primary outcomes (1)
- measure
- Performance of manually identified VLE features in predicting biopsy defined dysplasia
- timeFrame
- Up to 2 years post data collection
- description
- To determine the per-biopsy performance of a multivariable model consisting of manually-identified VLE features for predicting biopsy-defined dysplasia
Secondary outcomes (3)
- measure
- Per Patient Sensitivity and specificity for detecting dysplasia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over the age of 18. * Patients undergoing an upper endoscopy for BE surveillance with prior biopsy-confirmed BE with dysplasia (at least LGD). * 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 BE at time of study EGD. * Patients for whom use of the NvisionVLE device would be in conflict with the Instructions for Use (IFU). * Prior esophageal or gastric surgical resection. * Significant esophageal stricture requiring dilatation. * Patients who require anticoagulation for whom biopsy would be contraindicated. * Patients who are known to be pregnant.
References
Publications (0)
Data not yet available
No reference posted for this study.