NCT05349240

C2 Esophageal Squamous Epithelium Dysplasia

A Prospective, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of C2 CryoBalloonTM Ablation System in Patients With Esophageal Squamous Epithelium Dysplasia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (estimated)
• Sponsor: Pentax Medical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of C2 CryoBalloonTM Ablation System for the cryoablation of dysplastic squamous tissue in patients with moderate to severe esophageal squamous epithelium dysplasia.

Conditions

• Esophageal Squamous Epithelium Dysplasia

Interventions

Type	Name	Description
DEVICE	C2 CryoBalloonTM Ablation System.	Cryoablation is used to ablate the tissue under the cryogenic condition. The device is mainly used to destroy the unhealthy tissues.

Timeline

• Start date: 2022-11-18
• Primary completion: 2025-03-30
• Completion: 2026-07-31
• First posted: 2022-04-27
• Last updated: 2025-01-13

Locations

4 sites across 1 country: China

Regulatory

• FDA-regulated device study