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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02947971
Collaborator
National Institutes of Health (NIH) (NIH), National Cancer Institute (NCI) (NIH)
20
Enrollment
1
Location
1
Arm
91.5
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Experimental OFDI Imaging
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Apr 15, 2016
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: OFDI Imaging

Experimental OFDI Imaging

Device: Experimental OFDI Imaging
Imaging of the esophagus with a compact OFDI system and distal scanning catheter

Outcome Measures

Primary Outcome Measures

  1. Assessment of quality and performance of Compact Imaging System (CIS) [5-7 Minutes of imaging]

    Images obtained from the CIS will be assessed for quality and compared to images acquired from the previous imaging system

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Guillermo Tearney, MD, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02947971
Other Study ID Numbers:
  • 2015-P000587
  • 5R01CA184102-02
First Posted:
Oct 28, 2016
Last Update Posted:
Jul 22, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital
Device
OFDI
Tethered Capsule Endomicroscopy
Additional relevant MeSH terms:
Barrett Esophagus

Study Results

No Results Posted as of Jul 22, 2021