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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months

Awards & highlights

ColdPlay2 Trial 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.Check my eligibility

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.See study design

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.

ColdPlay2 Trial 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.

ColdPlay2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Histological evaluation of treatment zone(s) for dysplasia

Deglutition Disorders

Secondary outcome measures

Therapeutic procedure

ColdPlay2 Trial Design

1Treatment groups

Experimental Treatment

Group I: CryoBalloon ablationExperimental Treatment1 Intervention

Patients having ablation of dysplastic tissue in esophagus.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,256 Previous Clinical Trials

14,820,018 Total Patients Enrolled

Pentax MedicalIndustry Sponsor

16 Previous Clinical Trials

1,443 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any opportunities to enroll in this trial?

"As per the clinicaltrials.gov portal, this particular medical investigation is not presently registering patients. Originally posted on April 1st 2015 and last updated May 11th 2022, there are currently no participants being accepted for this study - however 403 other trials have open recruitment at present."

Answered by AI

Recent research and studies

Gastrointestinal EndoscopyJournal

Multifocal Nitrous Oxide Cryoballoon Ablation with or Without EMR for Treatment of Neoplastic Barrett’s Esophagus (with Video)

Canto, Marcia Irene, Nicholas J. Shaheen, Jose Alejandro Almario, Lysandra Voltaggio, Elizabeth Montgomery, and Charles J. Lightdale. 2018. “Multifocal Nitrous Oxide Cryoballoon Ablation with or Without EMR for Treatment of Neoplastic Barrett’s Esophagus (with Video)”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2018.03.024.

clinicaltrials.govStudy

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

2015. "Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02534233.

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