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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202590
Recruitment Status : Active, not recruiting
First Posted : July 29, 2014
Last Update Posted : August 13, 2020
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

Study Description
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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 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Study to Image the Esophagus Using Spectrally Encoded Confocal Microscopy (SECM)
Actual Study Start Date : October 2013
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. SECM Imaging quality. Assessed qualitative values like resolution, tissue architecture, background scatter etc. [ Time Frame: A single 20 minute visit (5-7 minute imaging). ]
    An investigator will qualitatively assess the the Feasibility of SECM Capsule and Imaging in EoE participant versus Healthy Controls. He 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.

  2. Tolerability of SECM Capsule Imaging Procedure in Healthy and EoE Participant, measured by feedback scores. [ Time Frame: Questionnaire adminstered directly after the imaging portion has been completed. ]
    After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire. This entails questions about discomfort levels and the participants ability to tolerate the tether and capsule during the whole and parts of the procedures. using a 0 -10 scale, participants will score how comfortable the procedure was during each stage. 10 being the most discomfort and 0 being the least discomfort.


Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
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
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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


Locations
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United States, Massachusetts
Massachusetts General hospital
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
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Principal Investigator: Guillermo Tearney, MD., PhD Massachusetts General Hospital
More Information
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Responsible Party: Guillermo Tearney, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02202590    
Other Study ID Numbers: 2013-P000863
5R01DK091923-03 ( U.S. NIH Grant/Contract )
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Guillermo Tearney, Massachusetts General Hospital:
SECM
Esophagus
Eosinophilic Esophagitis
Allergy
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
 Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases