CryoBalloon Ablation for Barrett's Esophagus

(ColdPlayIII Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the CryoBalloon Focal Ablation System for individuals with Barrett's Esophagus, a condition where the esophagus lining changes. The goal is to assess the safety and effectiveness of this treatment for those who have not tried other treatments for this condition. The study seeks participants diagnosed with Barrett's Esophagus who have specific changes in their esophagus lining but have not yet received treatment.

As an unphased trial, this study allows participants to contribute to groundbreaking research that could lead to new treatment options.

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 prior data suggests that the CryoBalloon Ablation System is safe for treating Barrett's Esophagus?

Research has shown that the CryoBalloon Focal Ablation System is safe for people with Barrett's Esophagus. One study compared it to another treatment and found similar safety results. Another study confirmed its safety and effectiveness for treating Barrett's Esophagus. A report from a UK registry also supports its safety. Overall, these studies indicate that the CryoBalloon Focal Ablation System is well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

CryoBalloon Ablation is unique because it uses cryotherapy to treat Barrett's esophagus, a condition where the esophagus lining is damaged by stomach acid. Most treatments for Barrett's esophagus, like radiofrequency ablation, involve heat to remove abnormal cells. However, CryoBalloon Ablation uses extreme cold to target the affected tissue, potentially reducing pain and recovery time. Researchers are excited about this method because it offers a less invasive option with the possibility of fewer side effects and improved patient comfort compared to traditional heat-based treatments.

What evidence suggests that the CryoBalloon Ablation System is effective for Barrett's Esophagus?

Research has shown that the CryoBalloon Focal Ablation System, which participants in this trial will receive, effectively treats Barrett's Esophagus (BE). One study demonstrated that a 10-second treatment with the CryoBalloon completely removed the abnormal tissue in the esophagus. Other studies confirm that this treatment is both safe and effective. The CryoBalloon is promising because it targets and destroys damaged cells without affecting the surrounding healthy tissue. Overall, this treatment is considered a strong option for people with BE. ^{2 3 5 6 7}

Who Is on the Research Team?

Marcia Canto, MD

Principal Investigator

Johns Hopkins Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27997963/

Efficacy of the CryoBalloon Focal Ablation System for ... A recent dosimetry study, using the CryoBalloon Focal Ablation System (CryoBalloon), demonstrated that 10-second ablations result in complete eradication of BE.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0016510722017680

Comparison of focal cryoballoon ablation with 10- and 8- ... Focal cryoballoon ablation (FCBA) is currently being investigated for the treatment of Barrett's esophagus (BE)-related neoplasia in a European multicenter ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/33/NCT02534233/Prot_SAP_000.pdf

CryoBalloon Focal Ablation System Study C2 Therapeutics, Inc. Preliminary results show the full-circumferential system is safe and has good efficacy on the ... Barrett's Esophagus. Through evaluation of the ... outcomes with ...

4. gut.bmj.com gut.bmj.com/content/74/Suppl_1/A36

O56 Clinical evaluation of cryoballoon ablation for barrett's ... Conclusions These results from the UK cryoablation registry suggest that CbFA is a safe and effective treatment for BE-D and mirror findings from larger ...

5. journals.lww.com journals.lww.com/ajg/fulltext/2020/11000/multifocal_cryoballoon_ablation_for_eradication_of.23.aspx

Multifocal Cryoballoon Ablation for Eradication of Barrett's ... In patients with neoplastic BE, CBA was safe and effective. Head-to-head comparisons between CBA and other ablation modalities are warranted.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11394299/

Efficacy and Safety of Cryoablation in Barrett's Esophagus ... Conclusions: Cryoablation provides equal outcomes compared to RFA in the treatment of patients with BE, with the cryoballoon achieving ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K240457.pdf

July 24, 2024 PENTAX of America, Inc. Gurvinder Singh ... A multi-center retrospective study evaluated the C2 CryoBalloon ablation system focal for the treatment and management of GAVE. 28 subjects ...