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

NCT02202590 | Active Not Recruiting FDA Device

• 2 other identifiers: 2013-P0008635R01DK091923-03
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis

Keywords

SECM; Esophagus; Eosinophilic Esophagitis; Allergy

Outcome Measures

Primary Outcomes (2)

• SECM Imaging quality. Assessed qualitative values like resolution, tissue architecture, background scatter etc.

  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.

  A single 20 minute visit (5-7 minute imaging).

• Tolerability of SECM Capsule Imaging Procedure in Healthy and EoE Participant, measured by feedback scores.

  After participating in the study, the participants 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.

  Questionnaire adminstered directly after the imaging portion has been completed.

Study Arms (1)

Imaging

EXPERIMENTAL

Participant will swallow the SECM capsule and Imaging will be performed using the SECM Imaging system.

Device: SECM Capsule

Interventions

SECM Capsule DEVICE

Imaging of the esophagus using the SECM capsule and system

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:

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

You may not qualify if:

• Participants 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.
• Participants with prior endoscopic ablation or resection treatment of Barrett's Esophagus (BE)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Massachusetts General hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis; Hypersensitivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Guillermo Tearney, MD., PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: July 29, 2014
• Study Start: October 1, 2013
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)