Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction
Optical Coherence Tomography Based Screening and Surveillance of Esophagus and Gastroesophageal Junction
2 other identifiers
interventional
109
1 country
1
Brief 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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 20, 2011
CompletedFirst Posted
Study publicly available on registry
July 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2011
CompletedResults Posted
Study results publicly available
September 28, 2018
CompletedJanuary 18, 2023
January 1, 2023
5.2 years
July 20, 2011
July 27, 2018
January 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening
Collected entire distal esophagus OFDI Images analyzed and compared to the images obtained during standard of care surveillance endoscopy.
Images will be acquired during the OFDI imaging session which should take an average of 5 minutes
Study Arms (1)
Optical Frequency Domain imaging System
EXPERIMENTALOptical Frequency Domain Imaging (OFDI) balloon based imaging
Interventions
Optical Frequency Domain (OFDI) imaging of esophagus
Eligibility Criteria
You may qualify if:
- over the age of 18,
- capable of giving informed consent,
- are undergoing elective EGD, and
- if female are willing to take a pregnancy test
You may not qualify if:
- patients on oral anticoagulation medications,
- with a history of hemostasis disorders and
- patients that are pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Massachussetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gary Tearney, PI
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Guillermo Tearney, MD PhD
Massachussetts General Hospital
- PRINCIPAL INVESTIGATOR
Norman Nishioka, MD
Massachussetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pathology
Study Record Dates
First Submitted
July 20, 2011
First Posted
July 25, 2011
Study Start
September 1, 2006
Primary Completion
November 16, 2011
Study Completion
November 16, 2011
Last Updated
January 18, 2023
Results First Posted
September 28, 2018
Record last verified: 2023-01