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Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System

Primary Purpose

Barrett's Esophagus

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental OFDI Imaging
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 Device, OFDI, Tethered Capsule Endomicroscopy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • A previous diagnosis of BE (not an inclusion criteria for healthy volunteers)
  • Subjects must be over the age of 18 but less than 70 year of age.
  • Subjects must be able to give informed consent
  • Subjects must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.

Exclusion Criteria:

  • Subjects over 70 years of age
  • Subjects with the inability to swallow pills and capsules.
  • Subjects with a strong gag reflex
  • Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
  • Pregnancy. If the subject is unsure, she will be asked to take a pregnancy test.

Sites / Locations

  • Massachusetts General hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OFDI Imaging

Arm Description

Experimental OFDI Imaging

Outcomes

Primary Outcome Measures

Assessment of quality and performance of Compact Imaging System (CIS)
Images obtained from the CIS will be assessed for quality and compared to images acquired from the previous imaging system

Secondary Outcome Measures

Full Information

First Posted
April 14, 2016
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
NCT02947971
Brief Title
Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System
Official Title
Pilot Study for TCE (Tethered Capsule Endomicroscopy) Imaging of the Esophagus Using an OFDI (Optical Frequency Domain Imaging) Capsule With a Compact Imaging System
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2016 (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 goal of this research is to test a distal scanning capsule and a compact redesigned version of the OFDI imaging system in healthy and BE subjects to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.
Detailed Description
Ten healthy volunteer subjects and ten volunteers with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled in the study. The capsule is attached to a string-like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using peristalsis. Images of the esophagus will be acquired in real time to be analyzed later.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus
Keywords
Device, OFDI, Tethered Capsule Endomicroscopy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
OFDI Imaging
Arm Type
Experimental
Arm Description
Experimental OFDI Imaging
Intervention Type
Device
Intervention Name(s)
Experimental OFDI Imaging
Intervention Description
Imaging of the esophagus with a compact OFDI system and distal scanning catheter
Primary Outcome Measure Information:
Title
Assessment of quality and performance of Compact Imaging System (CIS)
Description
Images obtained from the CIS will be assessed for quality and compared to images acquired from the previous imaging system
Time Frame
5-7 Minutes of imaging

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A previous diagnosis of BE (not an inclusion criteria for healthy volunteers) Subjects must be over the age of 18 but less than 70 year of age. Subjects must be able to give informed consent Subjects must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure. Exclusion Criteria: Subjects over 70 years of age Subjects with the inability to swallow pills and capsules. Subjects with a strong gag reflex Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule. Pregnancy. If the subject is unsure, she will be asked to take a pregnancy test.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Gao, RN
Phone
617-643-6092
Email
Tearneylabtrials@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Anita Chung, RN
Phone
617-724-4515
Email
Tearneylabtrials@partners.org
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Gao, RN
Phone
617-643-6092
Email
Tearneylabtrials@partners.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System

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