NCT02605759

Coldplay Cryoablation of Dysplastic Squamous Tissue in Patients With Esophageal Squamous Cell Dysplasia

Clinical Study to Evaluate the Safety, Feasibility and Efficacy of the Coldplay CryoBalloon Focal Ablation System for the Cryoablation of Dysplastic Squamous Tissue in Patients With Esophageal Squamous Cell Dysplasia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Pentax Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of esophageal squamous cell dysplasia.

Detailed description

Multi-center, prospective, single arm, non-randomized study. The study will proceed in two phases: a pilot phase, followed by the feasibility, safety and efficacy phase. In the pilot phase, up to five (5) patients at one (1) site will be treated with the CryoBalloon Ablation System to confirm its safety and feasibility in the treatment of squamous dysplasia. The second phase will be conducted at two (2) centers and will enroll up to 50 subjects to evaluate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of squamous dysplasia.

Conditions

• Esophageal Squamous Cell Dysplasia

Interventions

Type	Name	Description
DEVICE	CryoBalloon Focal Ablation System	Positioned within the esophagus at the target location, the Balloon is simultaneously inflated and cooled with nitrous oxide. The nitrous oxide cools the inner Balloon surface. The Balloon remains stationary during the delivery of the nitrous oxide for the Cryoablation of Dysplastic Squamous Tissue in Patients with Esophageal Squamous Cell Dysplasia

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-01-27
• Completion: 2018-01-27
• First posted: 2015-11-16
• Last updated: 2022-04-20

Locations

1 site across 1 country: China