Imaging of the Esophagus Using a SECM Capsule

NCT03546660 | Withdrawn FDA Device

• 1 other identifier: 2018-P000844
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

EoE; Eosinophilic Esophagitis; Barrett's Esophagus; Capsule; SECM; Tethered Capsule Endomicroscopy

Outcome Measures

Primary Outcomes (1)

• Feasibility of imaging of the Esophagus using a SECM Capsule

  comparing SECM imaging of the esophagus obtained with a SECM capsule to histopathology.

  10 minutes (roughly the amount of time it takes to image the esophagus via SECM capsule)

Study Arms (1)

SECM capsule imaging

EXPERIMENTAL

Participant will swallow the SECM capsule and the imaging of the esophagus will be performed using a SECM optical system

Device: SECM capsule

Interventions

SECM capsule DEVICE

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

SECM capsule imaging

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants 18 years of age or older who are healthy and have no significant health related issues
• Participants 14 years of age of older who are undergoing evaluation for EoE
• Able to give informed consent or assent as per the age of the subject

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis; Barrett Esophagus

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Precancerous Conditions; Neoplasms

Study Officials

• Guillermo Tearney, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 6, 2018
• Study Start: January 1, 2025
• Primary Completion: June 13, 2025
• Study Completion: June 13, 2025
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)