SECM Capsule Imaging for Esophageal Conditions

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Inability to swallow, Esophageal fistula, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

84 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the SECM Capsule treatment for esophageal conditions?

Research shows that the SECM Capsule, a type of imaging device, can effectively visualize cellular changes in the esophagus, which helps in diagnosing conditions like eosinophilic esophagitis (a type of esophagus inflammation). This technology reduces errors in traditional biopsy methods by providing detailed images of large areas of the esophagus. ^{1 2 3 4 5}

Is SECM Capsule Imaging safe for humans?

Capsule endoscopy, including the esophageal capsule, is generally well-tolerated by most patients and has few side effects. It is considered safe even for patients with implantable cardiac devices, although there may be some interference with image quality in certain cases. ^{6 7 8 9 10}

How is the SECM Capsule treatment different from other treatments for esophageal conditions?

The SECM Capsule is unique because it allows for high-speed, detailed imaging of the esophagus at a microscopic level without the need for invasive biopsies, reducing sampling errors common in traditional methods. This capsule is swallowed by the patient and provides comprehensive images of large areas of the esophagus, which is not possible with standard endoscopic techniques. ^{2 3 4 5 11}

Research Team

Guillermo Tearney, MD., PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for healthy volunteers over 14 years old who may have or are suspected to have Eosinophilic Esophagitis (EoE). Participants must be able to swallow pills and not have esophageal strictures smaller than the capsule's diameter.

Inclusion Criteria

I am suspected to have EoE.

Subject must be able to give informed consent

I have been suspected of having EoE before.

Exclusion Criteria

I have a narrow or blocked esophagus due to a fistula or stricture.

Subjects with the inability to swallow pills and capsules

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants swallow the SECM capsule for esophageal imaging

20 minutes

1 visit (in-person)

Follow-up

Participants provide feedback on the tolerability of the SECM procedure

Directly after imaging

Treatment Details

Interventions

• SECM Capsule

Trial Overview The study is testing a new tool called SECM Capsule, which takes detailed images of the esophagus. The goal is to see if it's easy to use and comfortable for patients.

Participant Groups

Group I: Imaging Experimental Treatment 1 Intervention

Subject will swallow the SECM capsule and Imaging will be performed using the SECM Imaging system.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

Esophageal capsule endoscopy (ECE) is less effective and more costly than initial upper endoscopy (EGD) for screening Barrett's esophagus in 50-year-old men with chronic GERD, with EGD providing more life-years gained.

In a theoretical cohort of 10,000 patients, EGD costs $1988 and yields 18.54 life-years, while ECE costs $2392 for 18.36 life-years, making EGD the more cost-effective option at $4530 per life-year gained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-benefit analysis of capsule endoscopy compared with standard upper endoscopy for the detection of Barrett's esophagus. Gerson, L., Lin, OS.[2008]

References

1. England pubmed.ncbi.nlm.nih.gov

String esophageal capsule endoscopy with real-time viewing improves visualization of the distal esophageal Z-line: a prospective, comparative study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Large-area spectrally encoded confocal endomicroscopy of the human esophagus in vivo. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Comprehensive confocal endomicroscopy of the esophagus in vivo. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Comprehensive imaging of gastroesophageal biopsy samples by spectrally encoded confocal microscopy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A miniaturized, tethered, spectrally-encoded confocal endomicroscopy capsule. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Cost-benefit analysis of capsule endoscopy compared with standard upper endoscopy for the detection of Barrett's esophagus. [2008]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Capsule endoscopy--state of the art. [2007]

8. Egypt pubmed.ncbi.nlm.nih.gov

Capsule Endoscopy in Patients with Implantable Electromedical Devices is Safe. [2021]

9. Italy pubmed.ncbi.nlm.nih.gov

Capsule endoscopy: a comprehensive review. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Capsule endoscopy: a review. [2008]

11. United States pubmed.ncbi.nlm.nih.gov

Spectrally encoded confocal microscopy of esophageal tissues at 100 kHz line rate. [2021]