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

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators will conduct a large study in the primary care clinic to determine the feasibility of using tethered capsule endomicroscopy as a screening method for Barrett's esophagus (BE) in the primary care practice environment. The investigators are also determining the prevalence of Barrett's esophagus in a primary care practice cohort at MGH.

Will I have to stop taking my current medications?

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

Is tethered capsule endomicroscopy safe for humans?

Tethered capsule endomicroscopy (TCE) has been shown to be safe in studies involving patients with Barrett's esophagus and other digestive diseases. The procedure involves swallowing a small pill-like device to capture images of the esophagus, stomach, and duodenum without sedation, and it has been well-tolerated by patients with rare reports of adverse events. ^{1 2 3 4 5}

How does tethered capsule endomicroscopy differ from other treatments for Barrett's Esophagus?

Tethered capsule endomicroscopy (TCE) is unique because it involves swallowing a small pill that captures high-resolution images of the esophagus without the need for sedation, unlike traditional endoscopy. This method is less invasive, more comfortable for patients, and can be used in primary care settings for early screening of Barrett's Esophagus. ^{2 4 5 6 7}

What data supports the effectiveness of the treatment Tethered Capsule Endomicroscopy for Barrett's Esophagus?

Research shows that Tethered Capsule Endomicroscopy (TCE) is a safe and feasible method for screening Barrett's Esophagus, providing high-resolution images of the esophagus without the need for sedation. It has been well-received in primary care settings, indicating its potential as a useful screening tool for a broader population. ^{2 4 5 8 9}

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

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]

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]

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

Feasibility and Safety of Tethered Capsule Endomicroscopy in Patients With Barrett's Esophagus in a Multi-Center Study. [2023]

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

Tethered capsule endomicroscopy: from bench to bedside at a primary care practice. [2019]

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

Tethered capsule endomicroscopy for microscopic imaging of the esophagus, stomach, and duodenum without sedation in humans (with video). [2021]

4. England pubmed.ncbi.nlm.nih.gov

Tethered capsule en face optical coherence tomography for imaging Barrett's oesophagus in unsedated patients. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Capsule endoscopy: technique and indications. [2008]

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

Retention of small bowel capsule endoscopy. [2023]

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

Patient-Reported Outcomes and Preferences for Colon Capsule Endoscopy and Colonoscopy: A Systematic Review with Meta-Analysis. [2021]

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

Tethered capsule endomicroscopy enables less invasive imaging of gastrointestinal tract microstructure. [2021]

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

Tethered capsule endoscopy, a low-cost and high-performance alternative technology for the screening of esophageal cancer and Barrett's esophagus. [2019]