Using Spectrally Encoded Confocal Microscopy (SECM) to Visualise the Esophagus Using an SECM Probe

Not Applicable

Completed

• Conditions: Barrett's Esophagus
• Interventions: Device: SECM Probe

• Registration Number: NCT02210039
• Lead Sponsor: Massachusetts General Hospital

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 Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-08-04
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-06
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2018-07-18
• Results First Submitted QC: 2018-09-26
• Results First Posted: 2018-10-23
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SECM Probe Imaging	SECM Probe	SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Tolerability of the Procedure	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.

Trial Locations

Locations (1)

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