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Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Guillermo Tearney, Massachusetts General Hospital
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02202590
First received: June 11, 2014
Last updated: July 11, 2017
Last verified: July 2017
  Purpose
The goal of this study is to test the feasibility and the tolerability of a tethered spectrally encoded confocal microscopy (SECM) capsule and to use it to image the esophagus.

Condition Intervention Phase
Eosinophilic Esophagitis Device: SECM Capsule Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Screening
Official Title: Pilot Study to Image the Esophagus Using Spectrally Encoded Confocal Microscopy (SECM)

Resource links provided by NLM:


Further study details as provided by Guillermo Tearney, Massachusetts General Hospital:

Primary Outcome Measures:
  • Measure the tolerability of SECM Capsule and imaging in healthy subjects as well as patients with Eosinophilic Esophagitis. [ Time Frame: Images will be acquired during the SECM imaging session and should take an average of 10 minutes. ]
    After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire.


Secondary Outcome Measures:
  • Measure the feasibility of SECM Capsule and imaging in healthy subjects as well as patients with Eosinophilic Esophagitis. [ Time Frame: Measure the feasibility of SECM Capsule and imaging in healthy subjects as well as patients with Eosinophilic Esophagitis. ]
    An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. The images obtained by the SECM Capsule will be compared to the images obtained by clinical endoscopy if available.


Estimated Enrollment: 72
Study Start Date: October 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imaging
Subject will swallow the SECM capsule and Imaging will be performed using the SECM Imaging system.
Device: SECM Capsule
Imaging of the esophagus using the SECM capsule and system

Detailed Description:

72 subjects including healthy volunteers, patients with a suspicion of having Eosinophilic Esophagitis (EoE) and patients with a clinical diagnosis of EoE will be recruited and asked to swallow the SECM capsule while being awake and unsedated. The capsule is attached to a tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis.

As the capsule progresses, multiple 2-dimensional cross sectional images of the esophagus are acquired. Images are analyzed at a later stage.

  Eligibility

Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject must be a healthy volunteer
  • OR subject must have a suspicion of EoE
  • OR subject must have a prior clinical suspicion of EoE
  • Subject must be older than 14 years of age
  • Subject must be able to give informed consent

Exclusion Criteria:

  • Subjects with the inability to swallow pills and capsules.
  • Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02202590

Contacts
Contact: Guillermo Tearney, MD., PhD 617-724-2979 gtearney@partners.org
Contact: Catriona Grant, BSN, RN 617-724-7461 cngrant@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Guillermo Tearney, MD., PhD Massachusetts General Hospital
  More Information

Responsible Party: Guillermo Tearney, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02202590     History of Changes
Other Study ID Numbers: 2013-P-000863
5R01DK091923-03 ( U.S. NIH Grant/Contract )
Study First Received: June 11, 2014
Last Updated: July 11, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Guillermo Tearney, Massachusetts General Hospital:
SECM
Esophagus
Eosinophilic Esophagitis
Allergy

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2017