Tethered Capsule Endomicroscopy for Barrett's Esophagus

Not currently recruiting at 4 trial locations

Overseen By Emily Ryan, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Endoscopic ablation, Esophageal fistula, Pregnancy, others

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

Compensation: Varies

Number of Visits: 5

Duration: 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to examining Barrett's Esophagus, a condition where the esophageal lining changes, often due to acid reflux. Participants will swallow a small capsule attached to a tether, which uses imaging technology to examine the esophagus. Known as Tethered Capsule Endomicroscopy (TCE), this method aims to assess its effectiveness over three years. Individuals with Barrett's Esophagus who haven't reached certain advanced stages or undergone specific treatments may qualify. As an unphased study, this trial 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 tethered capsule endomicroscopy device is safe for Barrett's Esophagus?

Research has shown that tethered capsule endomicroscopy (TCE) is safe for humans. Studies found no negative side effects linked to the TCE procedure. Many patients even preferred it over traditional endoscopy. Participants have tolerated the procedure well, and it has successfully produced clear images of the esophagus in most cases. This suggests that TCE is a promising and safe option for those with 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 way to image Barrett's Esophagus. Unlike traditional endoscopy, which involves inserting a long tube with a camera down the throat, TCE uses a small capsule that you simply swallow. This capsule is equipped with Optical Frequency Domain Imaging (OFDI) technology, which provides high-resolution images of the esophagus lining. Researchers are excited about this method because it could make screening for Barrett's Esophagus more comfortable and accessible, potentially leading to earlier detection and better patient outcomes.

What evidence suggests that the tethered capsule endomicroscopy device is effective for Barrett's Esophagus?

Research has shown that Tethered Capsule Endoscopy (TCE) offers a promising method for examining Barrett's Esophagus. In one study, 85.2% of patients preferred TCE over traditional endoscopy, highlighting its appeal. The procedure is safe and well-tolerated, with no reported side effects. TCE produces clear images of the esophagus in 90% of cases, allowing doctors to see details without invasive methods. It also provides quick, painless 3D images of the upper digestive tract, making it a less stressful option for patients. Participants in this trial will undergo TCE using the OFDI capsule to image Barrett's Esophagus. ^{2 3 4 6 7}

Who Is on the Research Team?

Guillermo Tearney, MD, PhD

Principal Investigator

MGH

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Barrett's Esophagus (BE) but without severe cell changes or esophageal cancer. Participants must not eat solid food for at least 4 hours and only clear liquids for 2 hours before the procedure. They should be able to swallow capsules, give informed consent, and have had a standard EGD within the past 15 months.

Inclusion Criteria

I am over 18 years old.

I have Barrett's esophagus without severe changes or cancer, confirmed by a biopsy.

I have had or will have a standard EGD test within 15 months.

Exclusion Criteria

I have an esophageal fistula or stricture.

I have had a procedure to remove or destroy Barrett's esophagus.

Self reported pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Tethered Capsule Endomicroscopy (TCE) imaging to study the natural history of Barrett's Esophagus

3 years

Regular visits at 5 clinical centers

Follow-up

Participants are monitored for safety and effectiveness after the main study period

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Tethered Capsule Endomicroscopy (TCE)

Trial Overview The study tests Tethered Capsule Endomicroscopy (TCE), a less invasive way to monitor Barrett's Esophagus using a capsule device with imaging technology. Patients will be followed up for three years at multiple sites to see how well TCE works in detecting changes in the esophagus.

How Is the Trial Designed?

Group I: Experimental OFDI capsule imaging Experimental Treatment 1 Intervention

Participants will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system. Intervention: 'Tethered Capsule Endomicroscopy (TCE) Imaging of Barrett's esophagus using OFDI capsule

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Kansas City Veteran Affairs Medical Center

Collaborator

Trials

24

Recruited

8,600+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

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]

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/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, ...

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/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.

5. nature.com nature.com/articles/s41551-025-01462-0

Tethered optoacoustic and optical coherence tomography ... Here we report a demonstration of a tethered capsule endoscopy combining OCT and OPAM for identifying BE neoplasia. We show that O2E resolves ...

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

Feasibility and Safety of Tethered Capsule ... 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-center (5- ...

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) ...