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

Mass General Brigham

Status

Active, not recruiting

Conditions

Eosinophilic Esophagitis

Treatments

Device: SECM Capsule

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02202590

5R01DK091923-03 (U.S. NIH Grant/Contract)

2013-P000863

Details and patient eligibility

About

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.

Full 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.

Enrollment

96 estimated patients

Sex

All

Ages

14+ years old

Volunteers

Accepts Healthy Volunteers

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)