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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new capsule, called the SECM Capsule, which takes pictures of the esophagus (the tube connecting the throat to the stomach) to assess its safety and effectiveness. The trial examines how easy the capsule is to use and how comfortable it feels. It includes healthy participants and those who might have or are suspected of having eosinophilic esophagitis (EoE), a condition that can make swallowing difficult. Participants must be able to swallow pills and have no blockages in their esophagus. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future diagnostic methods.

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 prior data suggests that the SECM Capsule is safe for imaging the esophagus?

Research has shown that the SECM capsule is safe and easy to use for capturing images of the esophagus. In earlier studies, the SECM capsule successfully took images without causing unexpected problems. It functions like other endoscopy capsules already approved and safely used for examining the esophagus. Most people experience few or no side effects from these types of capsules. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SECM Capsule Imaging because it offers a non-invasive way to assess esophageal conditions. Unlike traditional endoscopy, which can be uncomfortable and requires sedation, this innovative capsule is simply swallowed and uses advanced imaging technology to capture detailed pictures of the esophagus as it travels through. This method not only provides high-resolution images but also promises a more comfortable experience for patients, potentially leading to earlier detection and better management of esophageal conditions.

What evidence suggests that the SECM capsule is effective for imaging esophageal conditions?

Research has shown that the SECM Capsule, used by participants in this trial, is promising for capturing images of the esophagus. Studies have found it effectively diagnoses and monitors conditions like eosinophilic esophagitis (EoE). The SECM Capsule resembles approved endoscopy capsules but provides more detailed images. Early results suggest it is safe and well-tolerated by patients. This technology could simplify and enhance the accuracy of diagnosing and tracking esophageal conditions. ^{1 3 4 5}

Who Is on the Research Team?

Guillermo Tearney, MD., PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Imaging Experimental Treatment 1 Intervention

Participant 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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3891332/

Tethered confocal endomicroscopy capsule for diagnosis ... This capsule will be a simpler and more effective device for diagnosing EoE and monitoring the therapeutic response of this disease.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03546660

Imaging of the Esophagus Using a SECM Capsule | ... 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) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5805683/

Clinical Translation of Tethered Confocal Microscopy ... The ability of the SECM TCE capsule to more thoroughly image the esophagus is specifically important for diagnosis, monitoring, and management ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02202590

Using Spectrally Encoded Confocal Microscopy (SECM) to ... 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 ...

5. withpower.com withpower.com/trial/phase-eosinophilic-esophagitis-9-2013-8f44e

SECM Capsule Imaging for Esophageal Conditions Capsule endoscopy, including the esophageal capsule, is generally well-tolerated by most patients and has few side effects. It is considered safe even for ...