Clinical trial · Interventional
Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus
Pilot Study to Evaluate OFDI Surveillance and Image Guided Biopsy of the Esophagus
NCT01439633CI-TRIAL-00038056completedN/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 specific aim of this study is to determine the feasibility of marking target pathologic locations identified on Optical Frequency Domain Imaging (OFDI) datasets using superficial cautery marks of the esophagus that are visible by endoscopy for subsequent guidance of biopsy.
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 marking | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MGH OFDI marking and imaging
- description
- OFDI imaging
- interventionNames
- Device: MGH OFDI marking
Primary outcomes (1)
- measure
- Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies.
- timeFrame
- day 1, during diagnostic procedure
- description
- Determination of the feasibility to mark targeted pathologic locations identified through OFDI imaging using superficial cautery marks.Verification by endoscopy and utilization of the marks for biopsy guidance.Images will be analyzed and compared to biopsies of the correlated marked tissue.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing an EGD for Barrett's esophagus surveillance with a prior confirmed Barrett's segment at least 1 cm in length * 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 anti-platelet and anti-coagulation medications and NSAIDS at the time of procedure * Patients with a history of hemostasis disorders * Patients that are pregnant * Patients with esophageal strictures
References
Publications (1)
- DERIVEDSuter MJ, Gora MJ, Lauwers GY, Arnason T, Sauk J, Gallagher KA, Kava L, Tan KM, Soomro AR, Gallagher TP, Gardecki JA, Bouma BE, Rosenberg M, Nishioka NS, Tearney GJ. Esophageal-guided biopsy with volumetric laser endomicroscopy and laser cautery marking: a pilot clinical study. Gastrointest Endosc. 2014 Jun;79(6):886-96. doi: 10.1016/j.gie.2013.11.016. Epub 2014 Jan 23. PMID 24462171