CryoBalloon Ablation for Barrett's Esophagus

(ColdPlayIII Trial)

Recruiting at 10 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pentax Medical

Disqualifiers: Esophageal cancer, Esophageal varices, Hiatal hernia, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

150 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. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the CryoBalloon Ablation treatment for Barrett's Esophagus?

Research shows that the CryoBalloon Ablation treatment is effective in completely eradicating Barrett's Esophagus (BE) in targeted areas, with a study reporting 100% success in removing abnormal tissue in treated areas. Additionally, the treatment is considered safe and precise, with no significant complications observed. ^{1 2 3 4 5}

Is CryoBalloon Ablation safe for humans?

CryoBalloon Ablation has been studied for safety in treating Barrett's esophagus and other esophageal conditions. Research shows it is generally safe, with studies indicating it is feasible and well-tolerated in both human and animal models. ^{1 2 3 4 6}

How does the CryoBalloon Ablation treatment for Barrett's Esophagus differ from other treatments?

The CryoBalloon Ablation treatment is unique because it uses a balloon to deliver cold therapy precisely to the affected areas, which can be more targeted and efficient compared to other methods like radiofrequency ablation (RFA) or spray cryoablation (SCA). It simplifies the procedure by eliminating the need for sizing and multiple deployment steps, and it allows for precise dosing without the need for gas-venting. ^{2 3 4 5 6}

What is the purpose of this trial?

To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)

Research Team

Marcia Canto, MD

Principal Investigator

Johns Hopkins Medical Center

Eligibility Criteria

This trial is for adults over 18 with Barrett's Esophagus (BE) that hasn't been treated before. Participants must be able to follow the study plan and have BE confirmed by lab tests, without large hiatal hernias or esophageal varices. They can't join if they have uncontrolled bleeding disorders, severe narrowing of the esophagus, extensive cancer history beyond early stage, active severe inflammation of the esophagus, or are pregnant.

Inclusion Criteria

Provides written informed consent on the approved informed consent form

Willing and able to comply with study requirements for follow-up

My Barrett's Esophagus has not been treated and was confirmed by a tissue analysis.

Exclusion Criteria

I have had swollen veins in my esophagus.

Severe medical comorbidities precluding endoscopy

Pregnant or planning to become pregnant during period of study participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CryoBalloon ablation treatment for Barrett's epithelium, with up to five sessions allowed over 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of pain and dysplasia progression

12 months

Treatment Details

Interventions

• CryoBalloon Focal Ablation System

Trial Overview The CryoBalloon Focal Ablation System is being tested for its effectiveness and safety in treating Barrett's Esophagus. This device freezes affected tissue to remove it. The study involves people who haven't had previous treatments for their condition and will track how well they respond to this new method.

Participant Groups

Group I: CryoBalloon Ablation System Experimental Treatment 1 Intervention

Cryoablation treatment of patients with previously untreated (treatment naïve) Barrett's epithelium.

CryoBalloon Focal Ablation System is already approved in European Union, United States, China for the following indications:

Approved in European Union as C2 CryoBalloon Ablation System for:

• Ablation of unwanted tissue in the gastrointestinal tract, including treatment of Barrett’s Esophagus and squamous dysplasia with application of extreme cold

Approved in United States as C2 CryoBalloon Ablation System for:

• Ablation of Barrett’s esophagus with dysplasia

Approved in China as C2 CryoBalloon Ablation System for:

• Treatment of Esophageal Squamous Cell Neoplasia (ESCN)

Who Is Running the Clinical Trial?

Pentax Medical

Lead Sponsor

Trials

18

Recruited

1,600+

Findings from Research

In a study involving 80 patients with esophageal squamous cell neoplasia, the cryoballoon focal ablation system (CbFAS) demonstrated a high efficacy rate, achieving complete response in 97% of patients after 12 months, indicating its effectiveness for treating this condition.

The CbFAS was found to be safe and well tolerated, with no serious adverse events reported, and only minor self-limiting mucosal lacerations occurring in a few patients, suggesting it is a promising alternative to traditional treatments like EMR and ESD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study of endoscopic focal cryoballoon ablation for esophageal squamous cell neoplasia in China. Ke, Y., van Munster, SN., Xue, L., et al.[2021]

The study demonstrated that combining endoscopic resection (ER) with the Cryoballoon focal ablation system (CbFAS) is technically feasible in porcine models, indicating potential for effective treatment of dysplastic Barrett's esophagus.

No significant tissue damage differences were observed between CbFAS alone and the combination therapy, suggesting that the combination does not increase risks of complications such as bleeding or perforation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic resection combined with the Cryoballoon focal ablation system in the porcine normal esophagus: a preclinical study. Sunakawa, H., Yoda, Y., Takeshita, N., et al.[2021]

The Cryoballoon Focal Ablation System (CbFAS) is a safe and feasible method for treating Barrett's epithelium, with no major adverse events reported and only minor complications observed in a study of 39 patients.

The treatment resulted in full squamous regeneration in 82% of areas treated with 8 seconds of ablation and 100% in areas treated with 10 seconds, indicating effective dose response and potential for successful outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Barrett's esophagus with a novel focal cryoablation device: a safety and feasibility study. Schölvinck, DW., Künzli, HT., Kestens, C., et al.[2022]

The novel 90°-swipe cryoballoon ablation system (CbSAS90) demonstrated a high technical success rate of 92% in treating dysplastic Barrett's esophagus (BE) in a study of 25 patients, indicating its feasibility and effectiveness for ablating larger areas.

The treatment resulted in significant BE surface regression, with a median of 85% regression at the effective dose, while post-procedural pain and dysphagia were low, suggesting a favorable safety profile, although further evaluation is needed to optimize the balance between safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel cryoballoon ablation system for eradication of dysplastic Barrett's esophagus: a first-in-human feasibility study. van Munster, SN., Overwater, A., Raicu, MGM., et al.[2021]

In a study involving 30 patients with Barrett's esophagus, a 10-second cryoablation using the CryoBalloon successfully targeted 94% of the BE islands, demonstrating effective treatment precision.

Complete eradication of intestinal metaplasia and dysplasia was achieved in all areas that were completely ablated, with no reported complications such as stenoses, indicating a safe and effective intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the CryoBalloon Focal Ablation System for the eradication of dysplastic Barrett's esophagus islands. Künzli, HT., Schölvinck, DW., Meijer, SL., et al.[2018]

In a study of 311 patients with dysplastic Barrett's esophagus, both cryoballoon ablation (CBA) and radiofrequency ablation (RFA) showed similar effectiveness in achieving complete remission of intestinal metaplasia and dysplasia, indicating that both methods are viable options for endoscopic eradication therapy.

However, CBA was associated with a higher rate of strictures (10.4%) compared to RFA (4.4%), suggesting that while both techniques are effective, CBA may carry a greater risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative outcomes of radiofrequency ablation and cryoballoon ablation in dysplastic Barrett's esophagus: a propensity score-matched cohort study. Agarwal, S., Alshelleh, M., Scott, J., et al.[2022]

References

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

Prospective study of endoscopic focal cryoballoon ablation for esophageal squamous cell neoplasia in China. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Endoscopic resection combined with the Cryoballoon focal ablation system in the porcine normal esophagus: a preclinical study. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Treatment of Barrett's esophagus with a novel focal cryoablation device: a safety and feasibility study. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

A novel cryoballoon ablation system for eradication of dysplastic Barrett's esophagus: a first-in-human feasibility study. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of the CryoBalloon Focal Ablation System for the eradication of dysplastic Barrett's esophagus islands. [2018]

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

Comparative outcomes of radiofrequency ablation and cryoballoon ablation in dysplastic Barrett's esophagus: a propensity score-matched cohort study. [2022]