Pilot Study to Image the Esophagus Using a SECM Tethered Endoscopic Capsule

Healthy Clinical Trial

— SECM  

Official title:

Pilot Study for Imaging of Barrett's Esophagus Using an Spectrally Encoded Confocal Microscopy Tethered Endoscopic Capsule

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02445014
• Other study ID #: 2014-P-002058
• Secondary ID: 1R01CA184102-01
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: March 2020

Study information

• Verified date: August 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this research is to test the imaging quality of the modified, larger diameter, tethered Spectrally Encoded Confocal Microscopy (SECM) capsule in healthy subjects, subjects with Barrett's Esophagus (BE), and subjects with Gastroesophageal reflux disease (GERD).

Description:

36 subjects including 12 healthy volunteers, 12 patients with Barrett's Esophagus and 12 with Gastroesophageal reflux disease will be enrolled and asked to swallow the SECM HITEC Capsule. The subjects will be awake and unsedated.

The capsule is attached to a string like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis.

As the capsule progresses through the esophagus, multiple images of the esophagus are acquired in real time to be analyzed later.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: March 2020
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must be 1) a healthy volunteer (18 years or older), or 2) a subject with prior diagnosis of BE (18 years or older), or 3) a subject with prior diagnosis of GERD (18 years or older).

• AND Subject must be able to give informed consent.

• AND Subject must eat no solid foods for 8 hours before the procedure and only clear liquids for 2 hours before the procedure.

Exclusion Criteria:

• Subjects with any history of or known upper gastrointestinal strictures

• OR Subjects with a history of Crohn's disease,

• OR Subjects with difficulty swallow

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• Gastric Acid Reflux
• Gastroesophageal Reflux
• Healthy

Intervention

Device:
• MGH SECM Imaging Capsule
Imaging of the Esophagus using the SECM capsule and SECM Imaging system

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule.	The number of subjects from whom successful SECM imaging was obtained	20 minute visit (5-7 minute imaging)