Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-22 @ 10:44 AM
Study NCT ID:
NCT02534233
Status:
COMPLETED
Last Update Posted:
2025-08-01
First Post:
2015-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ColdPlay2
Brief Summary:
Assess Cryoablation (CryoBalloon Ablation cryotherapy) for treatment of Dysplastic Barrett's Esophagus, Esophageal Squamous Dysplasia and early Esophageal Cancer. The cryoablation treatment will be offered as an alternative to standard ablation therapies such as Radiofrequency Ablation, Argon Plasma Coagulation and carbon dioxide Cryotherapy).
Detailed Description:
Cryoablation (cryotherapy) is an established type of mucosal ablation for treatment of various conditions in the GI tract, including Barrett's esophagus and esophageal cancer. The purpose of this study is to assess the safety, feasibility and performance of cryoablation system (the C2 Focal Cryoablation Device in patients with BE and esophageal squamous dysplasia who need ablation therapy for clinical standard care. The new cryoablation treatment will be offered as an alternative to standard ablation therapies already in place (radiofrequency ablation, carbon dioxide cryotherapy).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: