N/A
Completed N=17
Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation
Source: ClinicalTrials.gov NCT01439594 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions — 64; 29 Imaging sessions
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions |
64; 29 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01439594). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.