N/A
N=22
Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus
Barrett's Esophagus
Bottom Line
View on ClinicalTrials.gov: NCT01439633 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies. — 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MGH OFDI marking (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies. |
22 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01439633). 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.