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

Barrett's Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02422433
• Other study ID #: 2013-P001254
• Secondary ID: 5R01CA103769-08
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2014
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Intervention

Device:
• OFDI Capsule Marking
Marking and imaging of the esophagus using the OFDI Capsule and system.

Locations

Country	Name	City	State
United States	Massachusetts General hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the marking OFDI capsule for diagnosing BE by comparing OFDI images and biopsy diagnosis	The images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.	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
Secondary	Sensitivity of the marking OFDI Capsule to correctly detect and mark the region of interest in BE	The images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.	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