Back to resultsStudy to Image the Esophagus Using the OFDI Capsule
Primary Purpose
Barrett's Esophagus, Eosinophilic Esophagitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OFDI Capsule
Sponsored by
About this trial
This is an interventional diagnostic trial for Barrett's Esophagus focused on measuring Optical Coherence Tomography, Barrett's Esophagus, Esophagus, Imaging
Eligibility Criteria
Inclusion Criteria:
- A previous diagnosis of Barrett's Esophagus
- OR a previous diagnosis of EoE
- OR a previous diagnosis of Gastroesophageal reflux disease (GERD)
- Subject must be 18 years or older in case of Barrett's and GERD, and over the age of 16 years for EoE
- Subject must be able to give informed consent
Exclusion Criteria:
- Subjects with known esophageal strictures, intestinal strictures or dysphagia
- OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OFDI Capsule Imaging
Arm Description
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.
Outcomes
Primary Outcome Measures
Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule
Number of subjects from whom the quality OFDI imaging was obtained
Secondary Outcome Measures
Full Information
NCT ID
NCT02204150
First Posted
June 12, 2014
Last Updated
April 22, 2019
Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02204150
Brief Title
Study to Image the Esophagus Using the OFDI Capsule
Official Title
Pilot Study for Imaging of the Esophagus Using an OFDI Capsule
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2012 (Actual)
Primary Completion Date
July 31, 2015 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)
Detailed Description
A total of 56 subjects with Barrett's Esophagus, EoE and healthy volunteers will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.
As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus, Eosinophilic Esophagitis
Keywords
Optical Coherence Tomography, Barrett's Esophagus, Esophagus, Imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OFDI Capsule Imaging
Arm Type
Experimental
Arm Description
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.
Intervention Type
Device
Intervention Name(s)
OFDI Capsule
Intervention Description
Imaging of the esophagus using the OFDI Capsule and system
Primary Outcome Measure Information:
Title
Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule
Description
Number of subjects from whom the quality OFDI imaging was obtained
Time Frame
Images will be acquired during the OFDI imaging session which should take an average of 5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A previous diagnosis of Barrett's Esophagus
OR a previous diagnosis of EoE
OR a previous diagnosis of Gastroesophageal reflux disease (GERD)
Subject must be 18 years or older in case of Barrett's and GERD, and over the age of 16 years for EoE
Subject must be able to give informed consent
Exclusion Criteria:
Subjects with known esophageal strictures, intestinal strictures or dysphagia
OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Tearney, MD., PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Image the Esophagus Using the OFDI Capsule
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