SHS_492309 LOUB CC2T 15255

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

To evaluate the efficacy and safety of the CryoBalloon Ablation System for the treatment of previously-untreated (treatment naive) Barrett's Esophagus (BE). Coldplay 3 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) Barrett's epithelium. Subjects may have a maximum of five (5) ablation treatment sessions during their 12 months of study participation to achieve complete eradication of their Barrett's epithelium. As many ablations as needed to treat the dysplastic areas are allowed in each treatment session.

Inclusion Criteria:

•Low- or high-grade non-nodular, previously untreated (treatment naive) dysplastic Barrett's epithelium, confirmed by histopathological analysis
•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
•Endoscopically-visualized abnormalities such as masses or nodules within 4cm of the treatment zone. Neoplastic nodules must first be treated with EMR ≥6 weeks prior to planned treatment under this protocol.
•History of esophageal cancer
•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 T1m 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 ≤2 years, as judged by the site investigator
Brian Louie, M.D.
C2 Therapeutics
Andrew Smith
  • Swedish Medical Center