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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Eosinophilic Esophagitis
• Intervention / Treatment: Device: SECM Capsule

Detailed Description

96 participants including healthy volunteers, patients with a suspicion of having Eosinophilic Esophagitis (EoE) and patients with a current or prior 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
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imaging; Participant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Guillermo Tearney, MD., PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: July 25, 2014
• First Posted (Estimated): July 29, 2014

Study Record Updates

• Last Update Posted (Estimated): October 22, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Allergy; Eosinophilic Esophagitis; SECM; Esophagus
• Additional Relevant MeSH Terms: Immune System Diseases; Digestive System Diseases; Gastrointestinal Diseases; Hypersensitivity, Immediate; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Esophageal Diseases; Gastroenteritis; Esophagitis; Hemic and Lymphatic Diseases; Hypersensitivity; Eosinophilic Esophagitis
• Other Study ID Numbers: 2013-P000863; 5R01DK091923-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No