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Cryoablation

CryoBalloon Ablation System for Barrett's Esophagus (ColdPlayIII Trial)

N/A
Waitlist Available
Led By Marcia Canto, MD
Research Sponsored by Pentax Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 and 36 months
Awards & highlights

ColdPlayIII Trial Summary

This trial is testing a new way to treat Barrett's Esophagus, a condition where the lining of the esophagus changes. They are testing to see if this new way is safe and effective.

ColdPlayIII Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 and 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 and 36 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
Incidence of serious, CryoBalloon Ablation System-related adverse events
LGD 1069
percentage of all treated patients who have complete eradication of all dysplasia (CE-D)
+1 more
Secondary outcome measures
Incidence of all treatment-related and all serious, non-treatment-related adverse events
Incidence of post procedure chest discomfort events / Pain score >0 and <5
Narcotic Analgesics
+6 more

ColdPlayIII Trial Design

1Treatment groups
Experimental Treatment
Group I: CryoBalloon Ablation SystemExperimental Treatment1 Intervention
Cryoablation treatment of patients with previously untreated (treatment naïve) Barrett's epithelium.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CryoBalloon Ablation System
2016
N/A
~10

Find a Location

Who is running the clinical trial?

Pentax MedicalLead Sponsor
16 Previous Clinical Trials
1,358 Total Patients Enrolled
Marcia Canto, MDPrincipal InvestigatorJohns Hopkins Medical Center
1 Previous Clinical Trials
2,000 Total Patients Enrolled

Frequently Asked Questions

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

Is enrollment available for this clinical experiment?

"Per clinicaltrials.gov, the recruitment period for this medical trial has ended; it was first posted on March 1st 2016 and last modified April 21 2022. Nevertheless, 36 other medical studies are still actively recruiting patients at this time."

Answered by AI

At how many locations is this clinical experiment being conducted?

"This trial is being conducted across 11 sites, comprising of the University Hospitals Cleveland Medical Center in Cleveland, University of North carolina School of Medicine in Chapel Hill and Sarasota Memorial Hospital in Sarasota. Additionally there are 8 other locations where this study will be taking place."

Answered by AI
Recent research and studies
American Journal of GastroenterologyJournal
Multifocal Cryoballoon Ablation for Eradication of Barrett's Esophagus-related Neoplasia: A Prospective Multicenter Clinical Trial
Canto, Marcia Irene, Arvind J. Trindade, Julian Abrams, Michael Rosenblum, John Dumot, Amitabh Chak, Prasad Iyer, et al.. 2020. “Multifocal Cryoballoon Ablation for Eradication of Barrett's Esophagus-related Neoplasia: A Prospective Multicenter Clinical Trial”. American Journal of Gastroenterology. Ovid Technologies (Wolters Kluwer Health). doi:10.14309/ajg.0000000000000822.
clinicaltrials.govStudy
Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System
2016. "Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02514525.
~17 spots leftby Apr 2025
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