Imaging of the Esophagus Using a SECM Capsule

Eosinophilic Esophagitis Clinical Trial

Official title:

Imaging of the Esophagus Using a SECM Capsule

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03546660
• Other study ID #: 2018-P000844
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: December 30, 2027

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Anita Chung, RN
• Phone: 617-724-4515
• Email: Tearneylabtrials[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Eosinophilic Esophagitis
• Esophagitis

Intervention

Device:
• SECM capsule
Subjects will swallow a SECM capsule and the SECM imaging will be performed

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