NCT02445014

Pilot Study to Image the Esophagus Using a SECM Tethered Endoscopic Capsule

Pilot Study for Imaging of Barrett's Esophagus Using an Spectrally Encoded Confocal Microscopy Tethered Endoscopic Capsule

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this research is to test the imaging quality of the modified, larger diameter, tethered Spectrally Encoded Confocal Microscopy (SECM) capsule in healthy subjects, subjects with Barrett's Esophagus (BE), and subjects with Gastroesophageal reflux disease (GERD).

Detailed description

36 subjects including 12 healthy volunteers, 12 patients with Barrett's Esophagus and 12 with Gastroesophageal reflux disease will be enrolled and asked to swallow the SECM HITEC Capsule. The subjects will be awake and unsedated. The capsule is attached to a string like 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 through the esophagus, multiple images of the esophagus are acquired in real time to be analyzed later.

Conditions

• Healthy
• Barrett's Esophagus
• Gastric Acid Reflux

Interventions

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

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-01-01
• Completion: 2020-03-01
• First posted: 2015-05-15
• Last updated: 2020-08-21
• Results posted: 2019-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study