Clinical trial NCT02422433: Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule
Official title: Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Barrett's Esophagus
Keywords: EGD
OFDI
Barrett's Esophagus
Imaging
Biopsy
OCT
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2015-04-21
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of the marking OFDI capsule for diagnosing BE by comparing OFDI images and biopsy diagnosis
timeFrame: 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 outcomes:
measure: Sensitivity of the marking OFDI Capsule to correctly detect and mark the region of interest in BE
timeFrame: 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
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: