CryoBalloon Ablation for Barrett's Esophagus

(NO FEAR-BE Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen by Nicholas J Shaheeen, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Severe comorbidities, Esophageal malignancy, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

A multicenter, prospective, single arm, non randomized clinical trial to evaluate the safety and efficacy of the C2 CryoBalloon Focal Ablation System (CbFAS) for the treatment of persistent dysplasia or intestinal metaplasia (IM) in the tubular esophagus after 3 or more radiofrequency ablations (RFA) for dysplastic BE, or \<50% eradication of Barrett's Esophagus (BE) after 2 RFA treatments.

Will I have to stop taking my current medications?

The trial requires participants to stop using anti-coagulation medications or non-aspirin anti-platelet agents for a certain period, as recommended for high-risk endoscopy procedures. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

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?

Research shows that the CryoBalloon Ablation System is generally safe for treating Barrett's esophagus and other esophageal conditions. Studies have found it to be feasible and safe in both human and animal models, with no major safety concerns reported.

^{2 3 4 5 6}

How is the CryoBalloon Ablation System treatment different from other treatments for Barrett's Esophagus?

The CryoBalloon Ablation System is unique because it uses cold energy to target and eradicate Barrett's Esophagus tissue, offering precise targeting and the ability to treat larger areas in a single step. Unlike other treatments like radiofrequency ablation, it does not require complex sizing or multiple deployment steps, making it simpler and potentially more efficient.

^{1 3 4 5 6}

Eligibility Criteria

This trial is for adults who've had at least 2-3 unsuccessful radiofrequency ablations to treat Barrett's Esophagus with dysplasia or intestinal metaplasia. Candidates should not have used certain esophageal treatments before, must be in good health overall, and willing to follow the study plan.

Inclusion Criteria

Provides written informed consent.

I have abnormal cell growth in my esophagus.

I am 18 years old or older.

Exclusion Criteria

I have or had high blood pressure in the liver or swollen veins in my esophagus.

Pregnant or planning to become pregnant during period of study participation.

My esophagus was narrow but has been widened to at least 15mm.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cryoballoon Focal Ablation System (CbFAS) treatment every 3 months +/- 6 weeks for up to 12 months or until complete eradication of intestinal metaplasia (CEIM) and dysplasia (CED) are achieved

Up to 12 months

Every 3 months +/- 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after achieving CEIM and CED, with follow-up visits at 3, 6, 9, and 12 months depending on baseline condition

12 months

3, 6, 9, and 12 months (for HGD or IMC); 6 and 12 months (for LGD)

Participant Groups

The NO FEAR-BE trial tests the C2 CryoBalloon Focal Ablation System's safety and effectiveness on patients whose Barrett's Esophagus hasn't improved after multiple radiofrequency ablations. It’s a single-group study without randomization.

Group I: Cryoballoon Focal Ablation System (CbFAS) Treatment Experimental Treatment 1 Intervention

Subjects undergoing CbFAS treatment as part of their clinical care for their condition.

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic Rochester Rochester, MN

UNC Chapel Hill Chapel Hill, NC

Icahn School of Medicine at Mount Sinai New York, NY

Johns Hopkins University Baltimore, MD

More Trial Locations

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill Lead Sponsor

PENTAX of America, Inc. Collaborator

Johns Hopkins University Collaborator

References

1. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of the CryoBalloon Focal Ablation System for the eradication of dysplastic Barrett's esophagus islands. [2018] Background and study aim&#8195;Cryoablation can be used for the treatment of Barrett's esophagus (BE). A recent dosimetry study, using the CryoBalloon Focal Ablation System (CryoBalloon), demonstrated that 10-second ablations result in complete eradication of BE. However, the efficacy of 10-second ablation in a larger cohort of patients has not been investigated, nor has the potential of precise targeting of specific areas. The aim of the study was to assess the efficacy and performance (i.&#8202;e. targeting of BE islands) of a 10-second cryoablation using the CryoBalloon. Results&#8195;A total of 30 patients were enrolled (worst pathology: low grade dysplasia in 14 [47&#8202;%], high grade dysplasia in 7 [23&#8202;%], early adenocarcinoma in 9 [30&#8202;%]). Of the 47 BE islands, 44 (94&#8202;%) were adequately targeted. Complete eradication of intestinal metaplasia and dysplasia was observed in 100&#8202;% of the completely ablated areas. No stenoses were observed. Conclusion&#8195;Cryoablation of BE islands using the CryoBalloon is effective. BE islands were effectively targeted.

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

Prospective study of endoscopic focal cryoballoon ablation for esophageal squamous cell neoplasia in China. [2021] Esophageal squamous cell neoplasia (ESCN) has a significant risk for progression to cancer. Current treatment options, endoscopic mucosal resection (EMR) or submucosal dissection (ESD), have their limitations. The cryoballoon focal ablation system (CbFAS) is a novel endoscopic ablation therapy device. We aimed to assess the safety, tolerability, and efficacy of CbFAS for eradication of ESCN.

3. England pubmed.ncbi.nlm.nih.gov

Endoscopic resection combined with the Cryoballoon focal ablation system in the porcine normal esophagus: a preclinical study. [2021] The Cryoballoon focal ablation system (CbFAS) for dysplastic Barrett's esophagus is simple, time-saving and has high therapeutic efficacy. This study aimed to evaluate the technical feasibility and tissue damage with combination therapy of endoscopic resection (ER) and CbFAS in porcine models.

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

Treatment of Barrett's esophagus with a novel focal cryoablation device: a safety and feasibility study. [2022] Currently, eradication of Barrett's epithelium is preferably achieved using radiofrequency ablation (RFA) or spray cryoablation (SCA). However, both modalities suffer from drawbacks such as the need for sizing, multiple deployment steps, large controller units (RFA), imprecise dosing and need for gas-venting (SCA). The new Cryoballoon Focal Ablation System (CbFAS) may address these limitations. This study assessed the safety, feasibility, and dose response of the CbFAS in patients with flat Barrett's epithelium with or without dysplasia.

5. 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] Label="BACKGROUND">Endoscopic cryoablation for Barrett's esophagus (BE) might offer advantages over heat-based ablation. Focal cryoballoon ablation has been promising for short-segment BE, whereas the novel 90&#176;-swipe cryoballoon ablation system (CbSAS90) ablates larger areas in a single step (90&#176; over 3&#8202;cm). The system allows for dose adjustment. CbSAS90 has been feasible and safe in animal and pre-esophagectomy studies. This is the first clinical study to assess feasibility, safety, and efficacy of CbSAS90 for eradication of dysplastic BE.

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] Strong evidence supports the use of radiofrequency ablation (RFA) in the management of dysplastic/neoplastic Barrett's esophagus (BE). Recently, the efficacy of the cryoballoon ablation (CBA) system was demonstrated in multicenter cohort studies. We aimed to assess the comparative effectiveness and safety of these 2 ablation modalities for endoscopic eradication therapy (EET) in a cohort study.