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

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus	Device: OFDI Capsule Marking	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 1, 2014

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OFDI Capsule Marking and Imaging 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.	Device: OFDI Capsule Marking Marking and imaging of the esophagus using the OFDI Capsule and system.

Arm

Intervention/Treatment

Experimental: OFDI Capsule Marking and Imaging

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.

Device: OFDI Capsule Marking

Marking and imaging of the esophagus using the OFDI Capsule and system.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.