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

Primary Purpose

Barrett's Esophagus, Esophageal Squamous Dysplasia, Esophageal Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CryoBalloon
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Barrett's Esophagus focused on measuring barrett's esophagus with dysplasia, early esophageal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CryoBalloon ablation

Arm Description

Patients having ablation of dysplastic tissue in esophagus.

Outcomes

Primary Outcome Measures

Histological evaluation of treatment zone(s) for dysplasia
evaluate histopathology of esophageal tissue for Barrett's dysplasia after cryoablation
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.

Secondary Outcome Measures

Histological evaluation of treatment zone for intestinal metaplasia (BE patients)
evaluate histopathology of esophageal tissue for Barrett's esophagus (intestinal metaplasia) after cryoablation

Full Information

First Posted
August 19, 2015
Last Updated
August 7, 2023
Sponsor
Johns Hopkins University
Collaborators
Pentax Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02534233
Brief Title
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium
Acronym
ColdPlay2
Official Title
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Pentax Medical

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus, Esophageal Squamous Dysplasia, Esophageal Cancer
Keywords
barrett's esophagus with dysplasia, early esophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CryoBalloon ablation
Arm Type
Experimental
Arm Description
Patients having ablation of dysplastic tissue in esophagus.
Intervention Type
Device
Intervention Name(s)
CryoBalloon
Other Intervention Name(s)
Cryoablation
Intervention Description
Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter
Primary Outcome Measure Information:
Title
Histological evaluation of treatment zone(s) for dysplasia
Description
evaluate histopathology of esophageal tissue for Barrett's dysplasia after cryoablation
Time Frame
60 months
Title
Number of patients with treatment-related adverse events (pain and dysphagia)
Description
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.
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Histological evaluation of treatment zone for intestinal metaplasia (BE patients)
Description
evaluate histopathology of esophageal tissue for Barrett's esophagus (intestinal metaplasia) after cryoablation
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcia Canto, MD, MPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29626424
Citation
Canto MI, Shaheen NJ, Almario JA, Voltaggio L, Montgomery E, Lightdale CJ. Multifocal nitrous oxide cryoballoon ablation with or without EMR for treatment of neoplastic Barrett's esophagus (with video). Gastrointest Endosc. 2018 Sep;88(3):438-446.e2. doi: 10.1016/j.gie.2018.03.024. Epub 2018 Apr 5.
Results Reference
derived

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

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