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

Mass General Brigham

Status: Completed

Conditions: Barrett's Esophagus

Treatments: Device: SECM Probe

Study type: Interventional

Funder types: Other

Identifiers

NCT02210039

2013-P-001213

Details and patient eligibility

About

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.

Full 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).

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

SECM Probe Imaging

Experimental group

Description:

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

Treatment:

Device: SECM Probe