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Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule

Primary Purpose

Barrett's Esophagus

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OFDI Capsule Marking
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Barrett's Esophagus focused on measuring EGD, OFDI, Barrett's Esophagus, Imaging, Biopsy, OCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must be undergoing an EGD.
  • Patients must be over the age of 18.
  • Patients must be able to give informed consent.

Exclusion Criteria:

  • Patients who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure.
  • OR patients with a history of hemostasis disorders.
  • OR patients with esophageal strictures.

Sites / Locations

  • Massachusetts General hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OFDI Capsule Marking and Imaging

Arm Description

Subject will swallow the OFDI capsule, marking will be performed by making superficial cautery marks on the tissue. This will be followed by imaging using the OFDI Imaging system.

Outcomes

Primary Outcome Measures

Feasibility of the marking OFDI capsule for diagnosing BE by comparing OFDI images and biopsy diagnosis
The images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.

Secondary Outcome Measures

Sensitivity of the marking OFDI Capsule to correctly detect and mark the region of interest in BE
The images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.

Full Information

First Posted
July 25, 2014
Last Updated
January 12, 2023
Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02422433
Brief Title
Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule
Official Title
Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2014 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

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

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research is to test the feasibility, sensitivity, and specificity of the marking Optical Frequency Domain Imaging (OFDI) capsule for diagnosing Barrett's Esophagus (BE).
Detailed Description
A total of 130 subjects scheduled to undergo esophagogastroduodenoscopy (EGD) 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. OFDI real-time images will be used for targeting of the region to be marked. Once in position, two cautery marks will be made to only the superficial layers of the esophageal mucosa. Following cautery marking, the capsule will be lowered in the esophagus and marked regions of interest will be reimaged for confirmation of the placement of potential cautery marks. Immediately following the completion of the experimental procedure, the standard of care with the performance of the surveillance endoscopy will be performed. Images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus
Keywords
EGD, OFDI, Barrett's Esophagus, Imaging, Biopsy, OCT

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OFDI Capsule Marking and Imaging
Arm Type
Experimental
Arm Description
Subject will swallow the OFDI capsule, marking will be performed by making superficial cautery marks on the tissue. This will be followed by imaging using the OFDI Imaging system.
Intervention Type
Device
Intervention Name(s)
OFDI Capsule Marking
Intervention Description
Marking and imaging of the esophagus using the OFDI Capsule and system.
Primary Outcome Measure Information:
Title
Feasibility of the marking OFDI capsule for diagnosing BE by comparing OFDI images and biopsy diagnosis
Description
The images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.
Time Frame
It is expected that the total experimental time including swallowing the OFDI capsule OFDI, OFDI imaging, and removal of the OFDI capsule will take approximately 20 minutes
Secondary Outcome Measure Information:
Title
Sensitivity of the marking OFDI Capsule to correctly detect and mark the region of interest in BE
Description
The images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.
Time Frame
It is expected that the total experimental time including swallowing the OFDI capsule OFDI, marking the region of interest, OFDI imaging, and removal of the OFDI capsule will take approximately 20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be undergoing an EGD. Patients must be over the age of 18. Patients must be able to give informed consent. Exclusion Criteria: Patients who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure. OR patients with a history of hemostasis disorders. OR patients with esophageal strictures.
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

Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule

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