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Imaging of the Esophagus Using a SECM Capsule

NCT03546660 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-10-22

No results posted yet for this study

Summary

The goal of this validation study is to compare Spectrally Encoded Confocal Microscopy (SECM) Tethered Capsule Endoscopy (TCE) diagnosis of Eosinophilic Esophagitis to that of standard of care endoscopic biopsy.

Conditions

  • Eosinophilic Esophagitis
  • Barrett Esophagus

Interventions

DEVICE

SECM capsule

Participants will swallow a SECM capsule and the SECM imaging will be performed

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Guillermo Tearney, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-06-13
Completion
2025-06-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03546660 on ClinicalTrials.gov