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

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02202590

Enrollment

Registered

2014-07-29

Start date

2013-10-31

Completion date

2028-12-31

Last updated

2025-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

Keywords

SECM, Esophagus, Eosinophilic Esophagitis, Allergy

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.

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.

Interventions

DEVICESECM Capsule

Imaging of the esophagus using the SECM capsule and system

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
SECM Imaging quality. Assessed qualitative values like resolution, tissue architecture, background scatter etc.	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.
Tolerability of SECM Capsule Imaging Procedure in Healthy and EoE Participant, measured by feedback scores.	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026