NCT02202590

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

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.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
DEVICE	SECM Capsule	Imaging of the esophagus using the SECM capsule and system

Timeline

• Start date: 2013-10-01
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2014-07-29
• Last updated: 2025-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study