Imaging of the Esophagus Using a SECM Capsule

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03546660

Collaborator

(none)

Enrollment

Location

Arm

43.9

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this validation study is to compare Spectrally Encoded Confocal Microscopy (SECM) Tethered Capsule Endoscopy (TCE) diagnosis of Eosinophilic Esophagitis to that of standard of care endoscopic biopsy.

Condition or Disease	Intervention/Treatment	Phase
Eosinophilic Esophagitis Barrett Esophagus	Device: SECM capsule	N/A

Detailed Description

Eosinophilic esophagitis is an inflammatory condition of the esophagus that occurs in response to certain foods or allergens. Approximately 300,000 people in the US have EoE, the incidence of newly diagnosed EoE is ~30,000/year, and EoE is found in 5-10% of all patients undergoing upper endoscopy. EoE is associated with debilitating symptoms, and is a common cause of dysphagia, strictures, and food impaction; it may even lead to esophageal perforation. Because of the impact of EoE on quality of life as well as the concern that this disease may progress to esophageal fibrosis with unknown long-term risks, experts recommend that EoE be treated until symptoms and eosinophilic infiltrate are resolved. Because the only objective method for diagnosing EoE is histopathologic assessment of multiple upper endoscopic biopsies, the processes of monitoring the esophagus during therapy and the food reintroduction involve a high number of repeat endoscopies. This process is both time consuming and frustrating for patients and their families. Because the endoscopic biopsy requires conscious sedation, it is also costly, exceeding $1000 per procedure. Given the rapid increase in the number of patients with this disease, there is a compelling need for a less invasive and more cost-effective means of identifying eosinophils in the esophagus.

Based on the extensive experience with Optical Coherence Tomography (OCT) and OFDI, the investigators at Tearney laboratory at MGH have developed a spectrally encoded confocal microscopy (SECM) technology that is able to acquire images at significantly higher frame rates than standard confocal microscopy. This SECM capability enables imaging of large portions of the esophagus at 2-µm resolution in realistic procedure times. Furthermore, the investigators at Tearney laboratory have created a tethered capsule SECM device that can be swallowed and used for EoE screening. The investigators at Tearney laboratory lab performed a pilot study using a SECM capsule on 58 subjects (2013-P-000863). The imaging was successful with no adverse or unanticipated events. SECM endoscopy capsule is similar to the approved endoscopy capsule.

A total of sixty (60) subjects will be recruited for this study. The imaging of the esophagus will be obtained. Subjects will not be sedated for the procedure.

The images obtained by the SECM capsule will be compared to the images obtained by the clinical endoscopy and biopsy. SECM imaging will be used for research purposes only and will not be used for diagnosis purposes.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Imaging of the Esophagus Using a SECM Capsule

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Aug 30, 2024

Anticipated Study Completion Date :

Aug 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SECM capsule imaging Subject will swallow the SECM capsule and the imaging of the esophagus will be performed using a SECM optical system	Device: SECM capsule Subjects will swallow a SECM capsule and the SECM imaging will be performed

Arm

Intervention/Treatment

Experimental: SECM capsule imaging

Subject will swallow the SECM capsule and the imaging of the esophagus will be performed using a SECM optical system

Device: SECM capsule

Subjects will swallow a SECM capsule and the SECM imaging will be performed

Outcome Measures

Primary Outcome Measures

Feasibility of imaging of the Esophagus using a SECM Capsule [10 minutes (roughly the amount of time it takes to image the esophagus via SECM capsule)]
comparing SECM imaging of the esophagus obtained with a SECM capsule to histopathology.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

12 years of age or older undergoing endoscopic biopsy for evaluation of EoE
Able to give informed consent

Exclusion Criteria:

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