CryoBalloon Focal Ablation System for Barrett's Esophagus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Barrett's Esophagus+2 MoreCryoBalloon Focal Ablation System - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new ablation system to treat persistent dysplasia or intestinal metaplasia in the esophagus after multiple failed attempts with another ablation system.

Eligible Conditions
  • Barrett's Esophagus
  • Intestinal Metaplasia
  • Esophageal Dysplasia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 19 Secondary · Reporting Duration: 12 months

12 months
Incidence of CryoBalloon-related serious adverse events
Percentage of all treated Subjects with complete eradication of all intestinal metaplasia (CEIM) within 12 months of enrollment.
Percentage of all treated subjects with complete eradication of dysplasia (CED) within 12 months of enrollment
Month 12
Mean number of CryoBalloon ablation treatments required to achieve CED and CEIM by 12 months from enrollment date.
Median number of CryoBalloon ablation treatments required to achieve CED and CEIM by 12 months from enrollment date.
Procedure success rate
Progression rate
Proportion of Barrett's Esophagus surface area reverted to neosquamous epithelium
Risk factors associated with failure to respond to CryoBalloon ablation
Survival curve analysis - time to CEIM
Survival curve analysis - time to progression
Survival curve analysis - time to recurrence
Technical success rate
Day 1
Pain
Median pain score - Day 1
Proportion of subjects requiring narcotic analgesic - Day 1
Day 30
Mean pain score - Day 30
Median pain score - Day 30
Proportion of subjects requiring narcotic analgesic - Day 30
Day 7
Mean pain score - Day 7
Median pain score - Day 7
Proportion of subjects requiring narcotic analgesic - Day 7

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Cryoballoon Focal Ablation System (CbFAS) Treatment
1 of 1

Experimental Treatment

70 Total Participants · 1 Treatment Group

Primary Treatment: CryoBalloon Focal Ablation System · No Placebo Group · N/A

Cryoballoon Focal Ablation System (CbFAS) Treatment
Device
Experimental Group · 1 Intervention: CryoBalloon Focal Ablation System · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CryoBalloon Focal Ablation System
2016
N/A
~80

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,370 Previous Clinical Trials
3,930,107 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,073 Previous Clinical Trials
31,017,155 Total Patients Enrolled
PENTAX of America, Inc.UNKNOWN
Nicholas J Shaheeen, MD, MPHPrincipal InvestigatorUNC Chapel Hill

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The lesion has an area of residual BE > 1 cm in diameter.\n
You have BE and a history of at least 2 RFA treatments and < 50% eradication of BE, as judged by estimation of the treating physician.
You are willing to undergo an alternative approved standard of care treatment for your condition.
You are willing and able to comply with study requirements for follow-up.
You have no prior history of balloon or spray cryotherapy esophageal treatment