Pilot Study to Image the Esophagus Using a SECM Probe
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Number of Participants With Tolerability of the Procedure
Study Overview
Brief Summary
The study is being done to test the feasibility and tolerability of a SECM imaging probe in patients with Barrett's Esophagus (BE).
Subjects will undergo SECM probe imaging while they are under conscious sedation. Spiral SECM imaging will be performed continuously over a pre-determined length. Patients will later be asked for their feedback.
Detailed Description
Subjects with a previous diagnosis of Barrett's Esophagus will be recruited in the study and undergo SECM probe imaging while using conscious sedation, pulse oximetry and blood pressure monitoring. The probe will be inserted the predetermined required distance in the esophagus using a guide wire.
Once the SECM imaging probe is in place, spiral SECM image data will be continuously collected over a pre-determined length (approximately 5cm).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A previous diagnosis of Barrett's Esophagus
- •Patients must be over the age of 18
- •Patient must be able to give informed consent
Exclusion Criteria
- •Subjects with any history of intestinal strictures
- •OR subjects with a history of prior GI surgery
- •OR subjects with a history of intestinal Crohn's disease.
Arms & Interventions
SECM Probe Imaging
SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.
Intervention: SECM Probe (Device)
Outcomes
Primary Outcomes
Number of Participants With Tolerability of the Procedure
Time Frame: During the procedure
We were monitoring the number of participants able to tolerate the procedure. All six participating subjects have been asked for a feedback about tolerability of the procedure using a specific tolerability questionnaire.
Secondary Outcomes
No secondary outcomes reported
Investigators
Guillermo Tearney
Professor of Pathology
Massachusetts General Hospital