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

Last updated: May 9, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Barrett's Esophagus

Esophageal Disorders

Heartburn

Treatment

Experimental OFDI Imaging

Clinical Study ID

NCT02947971
2015-P000587
5R01CA184102-02
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 clearliquids for 2 hours prior to the procedure.

Exclusion

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 issmaller than the diameter of the capsule.

  • Pregnancy. If the subject is unsure, she will be asked to take a pregnancy test.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Experimental OFDI Imaging
Phase:
Study Start date:
April 15, 2016
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Massachusetts General hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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