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

Sponsor
Johns Hopkins University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02534233
Collaborator
Pentax Medical (Industry)
53
Enrollment
1
Location
1
Arm
104
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: CryoBalloon
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium
Study Start Date :
Apr 1, 2015
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: CryoBalloon ablation

Patients having ablation of dysplastic tissue in esophagus.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Histological evaluation of treatment zone(s) for dysplasia [60 months]

      evaluate histopathology of esophageal tissue for Barrett's dysplasia after cryoablation

    2. Number of patients with treatment-related adverse events (pain and dysphagia) [60 months]

      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.

    Secondary Outcome Measures

    1. Histological evaluation of treatment zone for intestinal metaplasia (BE patients) [60 months]

      evaluate histopathology of esophageal tissue for Barrett's esophagus (intestinal metaplasia) after cryoablation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins Hospital Baltimore Maryland United States 21287

    Sponsors and Collaborators

    • Johns Hopkins University
    • Pentax Medical

    Investigators

    • Principal Investigator: Marcia Canto, MD, MPH, Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT02534233
    Other Study ID Numbers:
    • NA_00075654
    First Posted:
    Aug 27, 2015
    Last Update Posted:
    May 13, 2022
    Last Verified:
    May 1, 2022
    Keywords provided by Johns Hopkins University
    barrett's esophagus with dysplasia
    early esophageal cancer
    Additional relevant MeSH terms:
    Esophageal Neoplasms
    Barrett Esophagus

    Study Results

    No Results Posted as of May 13, 2022