Clinical trial · Interventional
Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation
Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing the Tissue Response to Radiofrequency Ablation
NCT01439594CI-TRIAL-00041853OFDIcompletedN/AResults postedClinicalTrials.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 goal of this research is to conduct a pilot clinical study to evaluate the potential use of esophageal Optical Frequency Domain Imaging (OFDI) for assessing the success and degree of injury associated with therapeutic radiofrequency ablation techniques.
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 |
|---|---|---|---|
| MGH OFDI Imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MGH OFDI Imaging
- description
- OFDI imaging
- interventionNames
- Device: MGH OFDI Imaging
Primary outcomes (1)
- measure
- Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions
- timeFrame
- During the OFDI imaging session (about 5 minutes)
- description
- Images will be taken and compared to standard of care biopsy to assess the success and degree of injury associated with radiofrequency ablation techniques. A successful imaging session is defined as any session where the OFDI device was able to take and produce discernible and clear data that is comparable to corresponding biopsy histopathology. It is considered unsuccessful if we were unable to produce OFDI data and/or attain a corresponding biopsy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a diagnosis of Barrett's esophagus * Patients undergoing an Esophagogastroduodenoscopy (EGD) * Patients scheduled for treatment with RF ablation or patients that have had previous BARRX RF ablation * Patients must be over the age of 18 * Patient must be able to give informed consent * Women with child bearing potential must have a negative pregnancy test prior to procedure Exclusion Criteria: * Patients on oral anticoagulation medications * Patients with a history of hemostasis disorders * Patients that are pregnant * Patients with esophageal strictures
References
Publications (0)
Data not yet available
No reference posted for this study.