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

Barrett's Esophagus Clinical Trial

Official title:

Pilot Study to Image the Esophagus Using a SECM Probe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210039
• Other study ID #: 2013-P-001213
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: April 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Intervention

Device:
• SECM Probe
Imaging of the esophagus using SECM probe and system.

Locations

Country	Name	City	State
United States	Massachusetts General hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Tolerability of 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.	During the procedure