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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• Esophageal Cancer
• Esophageal Neoplasms
• Esophageal Squamous Dysplasia

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