Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium (ColdPlay2)

Johns Hopkins University

Status: Completed

Conditions: Esophageal Cancer; Esophageal Squamous Dysplasia; Barrett's Esophagus

Treatments: Device: CryoBalloon

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02534233

NA_00075654

Details and patient eligibility

About

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).

Full 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).

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients recommended for ablation of either Barrett's esophagus with dysplasia or esophageal squamous dysplasia, scheduled for upper endoscopy.

Exclusion criteria

• Patient unable to undergo endoscopy,
• Patients with visible esophageal mass.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

CryoBalloon ablation

Experimental group

Description:

Patients having ablation of dysplastic tissue in esophagus.

Treatment:

Device: CryoBalloon