SECM Capsule Imaging for Eosinophilic Esophagitis

Overseen By Nitasha Bhat, MD

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 aims to determine if a new method for examining the esophagus, using a small capsule with a camera (SECM capsule), matches the effectiveness of the traditional method, which involves taking a tissue sample. The trial focuses on individuals with eosinophilic esophagitis (EoE), a condition causing esophageal inflammation, or those who are healthy without significant health issues. Participants must be able to swallow pills and should not have certain esophageal conditions, such as strictures too narrow for the capsule. Individuals experiencing EoE symptoms or undergoing evaluation for it may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance diagnostic methods for EoE.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that the SECM capsule is a promising tool for diagnosing conditions like Eosinophilic Esophagitis. Studies have found that patients can swallow this small device without needing sedation or anesthesia, making it easier and safer than traditional methods.

Early results suggest that patients tolerate the SECM capsule well. Testing has confirmed its technical and clinical effectiveness. Reports indicate that patients swallow the capsule without major issues, supporting its safety. Overall, the SECM capsule simplifies the diagnostic process and offers a less invasive, safer option for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SECM capsule imaging technique for eosinophilic esophagitis because it offers a non-invasive way to visualize the esophagus. Unlike current standard procedures like endoscopy, which can be uncomfortable and require sedation, the SECM capsule is swallowed like a pill and captures detailed images as it moves through the esophagus. This innovative method could provide a simpler, less intrusive option for diagnosing and monitoring the condition, potentially improving patient comfort and convenience.

What evidence suggests that SECM capsule imaging is effective for diagnosing Eosinophilic Esophagitis?

Research shows that the SECM capsule, used by participants in this trial, is designed to make diagnosing Eosinophilic Esophagitis (EoE) easier and more effective. EoE occurs when too many eosinophils, a type of white blood cell, accumulate in the esophagus. The capsule can scan the esophagus without sedation, increasing patient comfort. Studies have found that the capsule accurately identifies images of the esophagus to detect EoE. It also tracks the disease over time, which is crucial because traditional methods like endoscopic biopsies can be uncomfortable and costly. Overall, the SECM capsule is a promising tool for diagnosing and monitoring EoE. ^{1 2 3 6 7}

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 individuals aged 12 or older who are undergoing an endoscopic biopsy to evaluate Eosinophilic Esophagitis. Participants must be able to swallow pills and capsules, and cannot have esophageal strictures narrower than the capsule or esophageal fistula.

Inclusion Criteria

I am 12 or older and getting a biopsy to check for EoE.

Able to give informed consent

Exclusion Criteria

I have a narrow or blocked esophagus smaller than a capsule.

I cannot swallow pills or capsules.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

SECM Capsule Imaging

Participants swallow the SECM capsule for imaging of the esophagus using a SECM optical system

1 day

1 visit (in-person)

Comparison and Analysis

Images obtained by the SECM capsule are compared to clinical endoscopy and biopsy images for research purposes

2-4 weeks

Follow-up

Participants are monitored for any adverse events post-procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SECM capsule

Trial Overview The study is testing a new imaging technique called SECM Tethered Capsule Endoscopy (TCE) against the standard biopsy method for diagnosing Eosinophilic Esophagitis in the esophagus.

How Is the Trial Designed?

Group I: SECM capsule imaging Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

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 goal of this validation study is to compare Spectrally Encoded Confocal Microscopy (SECM) Tethered Capsule Endoscopy (TCE) diagnosis of Eosinophilic ...

3. nature.com nature.com/articles/s41598-018-20668-8

Clinical Translation of Tethered Confocal Microscopy ... In this paper, we report on technological and clinical feasibility of a swallowable tethered endomicroscopy capsule, which is administered without sedation.

4. giejournal.org giejournal.org/article/S0016-5107(19)31298-2/fulltext

Tu1963 AUTOMATED DIAGNOSIS OF EOSINOPHILIC ... To mitigate this issue, we trained a convolutional neural network (CNN) with 2,000 labeled images to classify HPF-sized SECM images as either EoE positive or ...

5. ui.adsabs.harvard.edu ui.adsabs.harvard.edu/abs/2017SPIE10040E..0GD/abstract

Tethered SECM endoscopic capsule for the diagnosis of ... This method of diagnosis is problematic because endoscopic biopsy is expensive and poorly tolerated and the esophageal eosinophil burden needs to be monitored ...

6. trials.foodallergy.org trials.foodallergy.org/trials/NCT02202590

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

7. withpower.com withpower.com/trial/phase-barrett-esophagus-2022-2caf3

SECM Capsule Imaging for Eosinophilic Esophagitis The SECM capsule, used for imaging the esophagus, is a swallowable device that does not require sedation or anesthesia, making it a relatively safe ...