ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02202590
Recruitment Status : Recruiting
First Posted : July 29, 2014
Last Update Posted : July 13, 2017
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

Brief Summary:
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 or disease Intervention/treatment Phase
Eosinophilic Esophagitis Device: SECM Capsule Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Pilot Study to Image the Esophagus Using Spectrally Encoded Confocal Microscopy (SECM)
Study Start Date : October 2013
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 )
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 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