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

Not Applicable

Completed

• Conditions: Gastric Acid Reflux; Healthy; Barrett's Esophagus
• Interventions: Device: MGH SECM Imaging Capsule

• Registration Number: NCT02445014
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-04-16
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-15
• Primary Completion: 2017-01
• Results First Submitted: 2019-03-28
• Results First Submitted QC: 2019-07-09
• Results First Posted: 2019-07-10
• Study Completion: 2020-03
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Subjects must be 1) a healthy volunteer (18 years or older), or 2) a subject with prior diagnosis of BE (18 years or older), or 3) a subject with prior diagnosis of GERD (18 years or older).
• AND Subject must be able to give informed consent.
• AND Subject must eat no solid foods for 8 hours before the procedure and only clear liquids for 2 hours before the procedure.

Exclusion Criteria

• Subjects with any history of or known upper gastrointestinal strictures
• OR Subjects with a history of Crohn's disease,
• OR Subjects with difficulty swallow

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MGH SECM Imaging Capsule	MGH SECM Imaging Capsule	Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system.

Primary Outcome Measures

Name	Time	Method
Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule.	20 minute visit (5-7 minute imaging)	The number of subjects from whom successful SECM imaging was obtained

Trial Locations

Locations (1)

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