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NCT02534233 Clinical Trial

Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium

Esophageal Cancer Clinical Trial

— ColdPlay2  

Official title:
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02534233
Other study ID # NA_00075654
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 2015
Est. completion date December 2024

Study information
Verified date May 2024
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 53
Est. completion date December 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CryoBalloon
Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter

Locations
Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (2)
Lead Sponsor Collaborator
Johns Hopkins University Pentax Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Histological evaluation of treatment zone(s) for dysplasia evaluate histopathology of esophageal tissue for Barrett's dysplasia after cryoablation 60 months
Primary Number of patients with treatment-related adverse events (pain and dysphagia) evaluate by patient questionnaire for change from baseline in pain on the 11 point scale (0-10) from baseline to post treatment and incidence of dysphagia (using a standardized dysphagia scoring system 0-4) collected over treatment period. 60 months
Secondary Histological evaluation of treatment zone for intestinal metaplasia (BE patients) evaluate histopathology of esophageal tissue for Barrett's esophagus (intestinal metaplasia) after cryoablation 60 months
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