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

Not Applicable

Active, not recruiting

• Conditions: Eosinophilic Esophagitis
• Interventions: Device: SECM Capsule

• Registration Number: NCT02202590
• Lead Sponsor: Massachusetts General Hospital

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

72 subjects including healthy volunteers, patients with a suspicion of having Eosinophilic Esophagitis (EoE) and patients with a 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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-07-25
• Study First Posted: 2014-07-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

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

Exclusion Criteria

• Subjects 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imaging	SECM Capsule	Subject will swallow the SECM capsule and Imaging will be performed using the SECM Imaging system.

Primary Outcome Measures

Name	Time	Method
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 subject 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.
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.

Trial Locations

Locations (1)

Massachusetts General hospital; 🇺🇸 Boston, Massachusetts, United States