Clinical trial · Observational
WavSTAT® Optical Biopsy System to Target Esophageal Biopsies
A Prospective Evaluation of the WavSTAT® Optical Biopsy System to Target Esophageal Biopsies: An Adjunctive Tool to Assist the Endoscopist to Identify Dysplasia or Cancer
NCT00747136CI-TRIAL-00021739terminatedClinicalTrials.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): Study has been terminated for inadequate results
Summary
Brief summary (as posted)
The purpose of this study is to demonstrate the clinical utility of the WavSTAT Optical Biopsy System as an adjunctive tool to improve the endoscopist's clinical sensitivity to identify dysplasia or cancer in the esophagus.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine sensitivity/specificity to identify dysplasia/cancer in the esophagus WavSTAT System alone, endoscopist alone/combination of WavSTAT and endoscopist. Sensitivity of the endoscopist will be compared to combination of endoscopist and WavSTAT.
- timeFrame
- 9-15 months estimated
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * The patient is between 18 and 80 years of age. * The patient is willing to sign an informed consent form. * The patient is a candidate for endoscopic examination * Female patients of child-bearing age, uncertain of pregnancy status, must have a negative pregnancy test. Exclusion Criteria: * The patient has congenital deformities, which preclude a physical biopsy procedure during endoscopy. * The patient is pregnant or nursing by admission. * The patient has other contraindications for physical biopsy.
References
Publications (0)
Data not yet available
No reference posted for this study.