N/A
N=109
Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction
Barrett's Esophagus
Bottom Line
View on ClinicalTrials.gov: NCT01401699 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening — 109 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Optical Frequency Domain Imaging (OFDI) (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening |
109 | — |
Summary
The specific aim of this study is to determine the accuracy of Optical Coherence Tomography (OCT) imaging for screening and diagnosis of the distal esophagus in patients undergoing a clinical esophagogastroduodenoscopy (EGD) procedure. The accuracy of results obtained using the developed OCT imaging probe will be determined and compared with those obtained through the traditional standard of care endoscopic biopsy .
Eligibility Criteria
Inclusion Criteria
- over the age of 18,
- capable of giving informed consent,
- are undergoing elective EGD, and
- if female are willing to take a pregnancy test
Exclusion Criteria
- patients on oral anticoagulation medications,
- with a history of hemostasis disorders and
- patients that are pregnant
Data sourced from ClinicalTrials.gov (NCT01401699). 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.