Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System

Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System for the Treatment of Patients With Previously Untreated Dysplastic Barrett's Epithelium

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

Coldplay III is a multi-center, prospective study that will provide evidence of the efficacy and safety of the System in treatment of patients with previously untreated (treatment naïve) low grade dysplasia (LGD) or high grade dysplasia (HGD) BE. Subjects may have a maximum of five (5) ablation treatment sessions during their 12 months of study participation to achieve complete eradication of their dysplastic BE and intestinal metaplasia. As many ablations as needed to treat the dysplastic areas are allowed in each treatment session at the discretion of the investigator.

Inclusion Criteria:

• Low- or high-grade non-nodular, previously untreated ("treatment naïve") dysplastic BE, confirmed by histopathological analysis. If nodular BE or Intramuscosal Cancer (ImCA) is identified during patient screening, this may be treated with Endoscopic Mucosal Resection (EMR) ≥6 weeks prior to treatment under this protocol. If previous EMR was performed, follow-up endoscopy must be negative for nodular BE. Patients with ImCA must be at low risk for recurrence, confirmed by EMR pathology results negative for positive margin, poorly differentiated carcinoma, and lymphovascular invasion.
• BE length ≤6cm excluding visible BE islands, and Prague Classification C ≥0 / M ≥1
• Older than 18 years of age at time of consent
• Operable per institution's standards
• Provides written informed consent on the approved informed consent form
• Willing and able to comply with study requirements for follow-up

Exclusion Criteria:

• Non-dysplastic or indefinite for dysplasia BE, confirmed by histopathological analysis
• Esophageal stenosis/stricture preventing advancement of a therapeutic endoscope (patients may have the stenosis/stricture dilated and then be treated with CryoBalloon ablation under this protocol at a subsequent procedure ≥2 weeks later)
• Symptomatic untreated strictures
• Any endoscopically-visualized abnormalities such as ulcers, masses or nodules. Neoplastic nodules must first be treated with EMR ≥6 weeks prior to planned treatment under this protocol.
• History of esophageal cancer more extensive than T1a or not meeting criteria for low risk of recurrence (confirmed by EMR pathology results negative for positive margin, poorly differentiated carcinoma, and lymphovascular invasion)
• History of esophageal varices
• Large (>4cm) hiatal hernia
• Prior distal esophagectomy
• Any clinical or histological suspicion of esophageal adenocarcinoma invading into the submucosa by endoscopic mucosal resection (EMR), or confirmed T1a cancer with positive deep margin by EMR
• Active esophagitis grade B or higher
• Severe medical comorbidities precluding endoscopy
• Uncontrolled coagulopathy
• Pregnant or planning to become pregnant during period of study participation
• Patient refuses or is unable to provide written informed consent
• Life expectancy ≤3 years, as judged by the site investigator
• General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation