Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus

Eosinophilic Esophagitis Clinical Trial

Official title:

Pilot Study to Image the Esophagus Using Spectrally Encoded Confocal Microscopy (SECM)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02202590
• Other study ID #: 2013-P000863
• Secondary ID: 5R01DK091923-03
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2013
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to test the feasibility and the tolerability of a tethered spectrally encoded confocal microscopy (SECM) capsule and to use it to image the esophagus.

Description:

72 subjects including healthy volunteers, patients with a suspicion of having Eosinophilic Esophagitis (EoE) and patients with a clinical diagnosis of EoE will be recruited and asked to swallow the SECM capsule while being awake and unsedated. The capsule is attached to a 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, multiple 2-dimensional cross sectional images of the esophagus are acquired. Images are analyzed at a later stage.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• Subject must be a healthy volunteer

• OR subject must have a suspicion of EoE

• OR subject must have a prior clinical suspicion of EoE

• Subject must be older than 14 years of age

• Subject must be able to give informed consent

Exclusion Criteria:

• Subjects with the inability to swallow pills and capsules.

• Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SECM Imaging quality. Assessed qualitative values like resolution, tissue architecture, background scatter etc.	An investigator will qualitatively assess the the Feasibility of SECM Capsule and Imaging in EoE participant versus Healthy Controls. He will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. The images obtained by the SECM Capsule will be compared to the images obtained by clinical endoscopy if available.	A single 20 minute visit (5-7 minute imaging).
Primary	Tolerability of SECM Capsule Imaging Procedure in Healthy and EoE Participant, measured by feedback scores.	After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire. This entails questions about discomfort levels and the participants ability to tolerate the tether and capsule during the whole and parts of the procedures. using a 0 -10 scale, participants will score how comfortable the procedure was during each stage. 10 being the most discomfort and 0 being the least discomfort.	Questionnaire adminstered directly after the imaging portion has been completed.