Tethered Capsule Endomicroscopy for Barrett's Esophagus

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

500 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Tethered Capsule Endomicroscopy (TCE) for Barrett's Esophagus?

Tethered Capsule Endomicroscopy (TCE) is shown to be a safe and feasible method for obtaining high-resolution images of the esophagus, which can help in diagnosing and planning treatment for Barrett's Esophagus. It is less invasive than traditional methods and can be used without sedation, making it a promising tool for screening and monitoring in a primary care setting. ^{1 2 3 4 5}

Is Tethered Capsule Endomicroscopy (TCE) safe for humans?

Tethered Capsule Endomicroscopy (TCE) has been tested for safety in humans, including those with Barrett's Esophagus, and studies have shown it to be a safe method for obtaining images of the esophagus, stomach, and duodenum without the need for sedation. ^{1 2 3 4 5}

How is tethered capsule endomicroscopy different from other treatments for Barrett's esophagus?

Tethered capsule endomicroscopy (TCE) is unique because it involves swallowing a small pill attached to a string that takes detailed images of the esophagus without the need for sedation, making it less invasive and more convenient than traditional endoscopy. This method allows for quick and easy screening in a primary care setting, potentially reaching a broader population. ^{1 2 3 4 5}

What is the purpose of this trial?

The goal of this research is to follow Barrett's Esophagus patients for 3 years using the tethered capsule endomicroscopy device with distal scanning and a compact imaging system in a multi-site clinical study.

Research Team

Guillermo Tearney, MD, PhD

Principal Investigator

MGH

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Experimental OFDI capsule imaging Experimental Treatment 1 Intervention

Subject 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+

Findings from Research

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]

References

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. Mexico pubmed.ncbi.nlm.nih.gov

Comparative evaluation of esophageal Barrett's epithelium through esophageal capsule endoscopy and methylene blue chromoendoscopy. [2015]

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

Cost-benefit analysis of capsule endoscopy compared with standard upper endoscopy for the detection of Barrett's esophagus. [2008]

5. 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]