Clinical trial · Interventional
Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule
NCT02422433CI-TRIAL-00096739active not recruitingN/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 purpose of this research is to test the feasibility, sensitivity, and specificity of the marking Optical Frequency Domain Imaging (OFDI) capsule for diagnosing Barrett's Esophagus (BE).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OFDI Capsule Marking | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OFDI Capsule Marking and Imaging
- description
- Participant will swallow the OFDI capsule, marking will be performed by making superficial cautery marks on the tissue. This will be followed by imaging using the OFDI Imaging system.
- interventionNames
- Device: OFDI Capsule Marking
Primary outcomes (1)
- measure
- Feasibility of the marking OFDI capsule for diagnosing BE by comparing OFDI images and biopsy diagnosis
- timeFrame
- It is expected that the total experimental time including swallowing the OFDI capsule OFDI, OFDI imaging, and removal of the OFDI capsule will take approximately 20 minutes
- description
- The images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be undergoing an EGD. * Patients must be over the age of 18. * Patients must be able to give informed consent. Exclusion Criteria: * Patients who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure. * OR patients with a history of hemostasis disorders. * OR patients with esophageal strictures.
References
Publications (0)
Data not yet available
No reference posted for this study.