Tethered Capsule Endomicroscopy for Barrett's Esophagus

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Age over 75, Dysphagia, GI strictures, 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 explores a new screening method for Barrett's esophagus, a condition where the esophageal lining changes and may lead to cancer. The test uses a small capsule on a string to capture images inside the esophagus, potentially making early detection easier and more comfortable in primary care settings. The study seeks participants who are patients at specific primary care practices and have fasted for at least one hour before the procedure. This trial aims to determine the prevalence of Barrett's esophagus in the general population. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance early detection methods for Barrett's 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 prior data suggests that tethered capsule endomicroscopy is safe for screening Barrett's esophagus?

Research has shown that tethered capsule endomicroscopy (TCE) is generally safe and well-tolerated. Studies have demonstrated that patients with Barrett's esophagus, a condition where the lining of the esophagus changes, underwent this procedure without serious issues. In 90% of these cases, high-quality images were captured, indicating effective performance.

The studies found the procedure safe, with participants reporting few side effects. Most people did not experience significant discomfort or problems during the test. Overall, TCE appears to be a promising and safe tool for screening Barrett's esophagus. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Tethered Capsule Endomicroscopy (TCE) is unique because it offers a non-invasive and patient-friendly way to screen for Barrett's Esophagus, a condition that can lead to esophageal cancer. Unlike traditional endoscopy, which can be uncomfortable and requires sedation, TCE involves swallowing a small capsule attached to a thin tether, which captures detailed images of the esophagus as it is gently pulled back up. Researchers are excited about TCE because it has the potential to be used easily in primary care settings, making screening more accessible and widespread. This could lead to earlier detection and treatment, ultimately improving patient outcomes.

What evidence suggests that tethered capsule endomicroscopy is effective for screening Barrett's esophagus?

Research has shown that tethered capsule endomicroscopy (TCE), which participants in this trial will undergo, is a promising method for detecting Barrett's esophagus. Studies have found that it provides clear images of the esophagus in 90% of patients. TCE is less invasive and more comfortable than traditional endoscopy, with no reported side effects. Many patients prefer TCE because it is simpler and painless. This technique has proven safe for people with Barrett's esophagus and other digestive issues. Overall, TCE appears to be an effective and preferred option for detecting Barrett's esophagus. ^{1 2 4 6 7}

Who Is on the Research Team?

Guillermo Tearney, M.D, PhD.

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 who are patients at the Assembly Row primary care practice, can consent to participate, and haven't eaten for an hour before the procedure. It's not for pregnant individuals, those with swallowing difficulties, urgent symptoms like fever or abdominal pain, a history of certain GI surgeries or Crohn's disease.

Inclusion Criteria

Subjects registered as patients at the Assembly Row primary care practice.

Able to give informed consent

Subject must have no food for 1 hour before the procedure

Exclusion Criteria

I am currently having difficulty swallowing.

I have a narrow GI passage, had GI surgery, or have Crohn's disease.

I am scheduled for an urgent care visit due to symptoms like fever or abdominal pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Participants undergo tethered capsule endomicroscopy to screen for Barrett's esophagus

30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Tethered Capsule Endomicroscopy

Trial Overview The study is testing tethered capsule endomicroscopy as a way to screen for Barrett's Esophagus in a regular doctor’s office setting. The goal is to see if this method works well in primary care and how common Barrett's Esophagus is among these patients.

How Is the Trial Designed?

Group I: Feasibility of TCE & Prevalence of BE Experimental Treatment 1 Intervention

1. Feasibility of using tethered capsule endomicroscopy as a screening method for Barrett's esophagus in the primary care practice environment 2. Determine the prevalence of Barrett's esophagus in a primary care practice cohort at MGH

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Ultrahigh-speed tethered capsule swept-source optical coherence tomography (SS-OCT) effectively imaged Barrett's oesophagus (BE) features in 16 unsedated patients, demonstrating good patient toleration and the ability to identify dysplastic changes.

The procedure achieved a mean capsule contact of 75% over BE and 59% longitudinal image coverage, indicating that while it can capture significant mucosal details, limited coverage may lead to sampling errors for focal pathologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tethered capsule en face optical coherence tomography for imaging Barrett's oesophagus in unsedated patients. Liang, K., Ahsen, OO., Murphy, A., et al.[2022]

Tethered capsule endomicroscopy (TCE) is a safe and effective method for obtaining high-resolution images of the esophagus in patients with Barrett's esophagus, with 93.7% of participants successfully completing the procedure and high-quality images obtained.

The imaging results from TCE showed a strong correlation with traditional endoscopic findings, indicating that TCE can be a reliable tool for screening and monitoring Barrett's esophagus, and it can be administered by non-expert personnel in a multi-center setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Tethered Capsule Endomicroscopy in Patients With Barrett's Esophagus in a Multi-Center Study. Dong, J., Grant, C., Vuong, B., et al.[2023]

Capsule endoscopy is a safe and effective method for examining the small bowel and colon, but there is a small risk of capsule retention, which can be managed conservatively with good outcomes.

To reduce the risk of capsule retention, careful patient selection and the use of patency capsules or imaging techniques like CT or MR enterography are recommended, although these methods do not completely eliminate the risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retention of small bowel capsule endoscopy. Rosa, B., Dray, X., Koulaouzidis, A.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3567218/

Tethered capsule endomicroscopy enables less-invasive ... This technique rapidly provides three-dimensional, microstructural images of the upper gastrointestinal tract in a simple and painless procedure.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1542356521001099

Feasibility and Safety of Tethered Capsule ... Here, we demonstrate and evaluate the feasibility and safety of TCE and a portable OCT imaging system in patients with Barrett's esophagus (BE) in a multi- ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04561791

Evaluation of Tethered Capsule Endomicroscopy as a ... The procedure has been safe and well tolerated. High quality microscopic images of the esophagus have been obtained in 90% of the enrolled participants.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8715859/

Feasibility and safety of tethered capsule endomicroscopy ... There were no adverse events associated with TCE procedure. The results showed that the majority (85.2%) stated that they likely preferred TCE over endoscopy, ...

5. withpower.com withpower.com/trial/phase-barrett-esophagus-2019-b9822

Tethered Capsule Endomicroscopy for Barrett's Esophagus Tethered capsule endomicroscopy (TCE) has been shown to be safe in studies involving patients with Barrett's esophagus and other digestive diseases. The ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33549871/

Feasibility and Safety of Tethered Capsule ... Here, we demonstrate and evaluate the feasibility and safety of TCE and a portable OCT imaging system in patients with Barrett's esophagus (BE) ...

7. cghjournal.org cghjournal.org/article/S1542-3565(21)00109-9/abstract

Feasibility and Safety of Tethered Capsule ... Here, we demonstrate and evaluate the feasibility and safety of TCE and a portable OCT imaging system in patients with Barrett's esophagus (BE) ...