RECRUITING

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

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Conditions

Barrett's EsophagusDeviceOFDITethered Capsule Endomicroscopy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 participants to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.

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

Quick Facts

Study Start:2016-04-15
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02947971

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * A previous diagnosis of BE (not an inclusion criteria for healthy volunteers)
  2. * Participants 18 years and older with a previous diagnosis of GERD
  3. * Participants 14 years and older with a previous diagnosis of EoE (not an inclusion criteria for healthy volunteers)
  4. * Health participants over the age of 18 but less than 85 years of age
  5. * Participants must be able to give informed consent
  6. * Participants must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.
  1. * Participants over 85 years of age
  2. * Participants with the inability to swallow pills and capsules.
  3. * Participants with a strong gag reflex
  4. * Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
  5. * Participants who are pregnant. In case of women of child bearing age, we will ask them if they are pregnant and if unsure; ask them to take a pregnancy test.

Contacts and Locations

Study Contact

Juleen Guoy, RN
CONTACT
617-726-5317
Tearneylabtrials@partners.org
Anita Chung, RN
CONTACT
617-724-4515
Tearneylabtrials@partners.org

Principal Investigator

Guillermo Tearney, MD, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Guillermo Tearney, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-04-15
Study Completion Date2028-12

Study Record Updates

Study Start Date2016-04-15
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Device
  • OFDI
  • Tethered Capsule Endomicroscopy

Additional Relevant MeSH Terms

  • Barrett's Esophagus