Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule

Not Applicable

Active, not recruiting

• Conditions: Barrett's Esophagus
• Interventions: Device: OFDI Capsule Marking

• Registration Number: NCT02422433
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The purpose of this research is to test the feasibility, sensitivity, and specificity of the marking Optical Frequency Domain Imaging (OFDI) capsule for diagnosing Barrett's Esophagus (BE).

Detailed Description

A total of 130 subjects scheduled to undergo esophagogastroduodenoscopy (EGD) will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.

OFDI real-time images will be used for targeting of the region to be marked. Once in position, two cautery marks will be made to only the superficial layers of the esophageal mucosa. Following cautery marking, the capsule will be lowered in the esophagus and marked regions of interest will be reimaged for confirmation of the placement of potential cautery marks.

Immediately following the completion of the experimental procedure, the standard of care with the performance of the surveillance endoscopy will be performed. Images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-25
• Study First Submitted QC: 2015-04-20
• Study First Posted: 2015-04-21
• 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: 130

Inclusion Criteria

• Patients must be undergoing an EGD.
• Patients must be over the age of 18.
• Patients must be able to give informed consent.

Exclusion Criteria

• Patients who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure.
• OR patients with a history of hemostasis disorders.
• OR patients with esophageal strictures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OFDI Capsule Marking and Imaging	OFDI Capsule Marking	Subject will swallow the OFDI capsule, marking will be performed by making superficial cautery marks on the tissue. This will be followed by imaging using the OFDI Imaging system.

Primary Outcome Measures

Name	Time	Method
Feasibility of the marking OFDI capsule for diagnosing BE by comparing OFDI images and biopsy diagnosis	It is expected that the total experimental time including swallowing the OFDI capsule OFDI, OFDI imaging, and removal of the OFDI capsule will take approximately 20 minutes	The images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.

Secondary Outcome Measures

Name	Time	Method
Sensitivity of the marking OFDI Capsule to correctly detect and mark the region of interest in BE	It is expected that the total experimental time including swallowing the OFDI capsule OFDI, marking the region of interest, OFDI imaging, and removal of the OFDI capsule will take approximately 20 minutes	The images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.

Trial Locations

Locations (1)

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