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OpenTrials
Completed

NCT Number: NCT02534233

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

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).

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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Dysplasia Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CryoBalloon

Device

Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter

Other names: Cryoablation

Primary outcomes

  1. Number of Participants With Complete Eradication of Esophageal Dysplasia

    Time frame: 12 months

    Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus or squamous dysplasia after cryoablation treatments (assess for complete eradication of dysplasia).

  2. Treatment-related Adverse Events Assessed by Pain Scale

    Time frame: 1 day post treatment (day 2), 1 week post treatment (day 8), and 1 month (day 31)

    Evaluate by patient questionnaire for pain on an 11-point scale. The 11-point Likert scale represents a range of discomfort or pain from 0 (no pain) to 10 (extreme pain), which individuals indicate their level of discomfort or pain. Higher score more discomfort.

    Each subject is evaluated for post-treatment pain after each cryoablation session. Subjects may have a different number of treatment sessions depending on the extent of disease.

  3. Treatment-related Adverse Events Assessed by Stricture Rate

    Time frame: Up to 12 months

    Number of patients with esophageal strictures requiring dilation. Patients reporting dysphagia with solid food, with balloon dilations from index visit to 12 months.

Secondary outcomes

  1. Number of Participants With Complete Eradication of Intestinal Metaplasia

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Pentax Medical

Registry information

Acronym: ColdPlay2

Important dates

Study start
2015
Primary completion
2024
Study completion
2025
First posted
Aug 27, 2015
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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