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Cryotherapy

CryoBalloon Ablation for Esophageal Cancer (ColdPlay2 Trial)

N/A
Waitlist Available
Led By Marcia Canto, MD, MPH
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients recommended for ablation of either Barrett's esophagus with dysplasia or esophageal squamous dysplasia, scheduled for upper endoscopy.
Be older than 18 years old
Must not have
Patient unable to undergo endoscopy,
Patients with visible esophageal mass.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess whether the cryoablation treatment is effective for Barrett's Esophagus, Esophageal Squamous Dysplasia and early Esophageal Cancer.

Who is the study for?
This trial is for patients recommended to receive ablation therapy for Barrett's esophagus with dysplasia, esophageal squamous dysplasia, or early-stage esophageal cancer. Participants must be scheduled for an upper endoscopy. Those who cannot undergo endoscopy or have a visible mass in the esophagus are excluded.
What is being tested?
The study tests CryoBalloon Ablation cryotherapy as an alternative treatment option to standard therapies like Radiofrequency Ablation and Argon Plasma Coagulation for certain types of abnormal tissue growth in the esophagus.
What are the potential side effects?
While specific side effects are not listed, typical risks may include discomfort at the treatment site, potential bleeding or tearing of the esophagus, and general risks associated with endoscopic procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a procedure to treat abnormal cells in my esophagus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot have an endoscopy.
Select...
I have a visible lump in my esophagus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Histological evaluation of treatment zone(s) for dysplasia
Deglutition Disorders
Secondary study objectives
Therapeutic procedure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CryoBalloon ablationExperimental Treatment1 Intervention
Patients having ablation of dysplastic tissue in esophagus.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,326 Previous Clinical Trials
14,874,906 Total Patients Enrolled
Pentax MedicalIndustry Sponsor
17 Previous Clinical Trials
1,515 Total Patients Enrolled
Marcia Canto, MD, MPHPrincipal InvestigatorJohns Hopkins University

Media Library

CryoBalloon (Cryotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02534233 — N/A
Esophageal Cancer Research Study Groups: CryoBalloon ablation
Esophageal Cancer Clinical Trial 2023: CryoBalloon Highlights & Side Effects. Trial Name: NCT02534233 — N/A
CryoBalloon (Cryotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02534233 — N/A
~3 spots leftby Aug 2025
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