N/A Completed N=22 Diagnostic

Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus

Source: ClinicalTrials.gov NCT01439633 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2018

Primary outcomePrimary: Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies. — 22 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies.	22	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.