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Active, Not Recruiting

NCT Number: NCT02202590

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SECM Capsule

Device

Imaging of the esophagus using the SECM capsule and system

Primary outcomes

  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 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2026
Study completion
2028
First posted
Jul 29, 2014
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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