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Cryoablation Device

CryoBalloon Ablation for Barrett's Esophagus (NO FEAR-BE Trial)

N/A
Recruiting
Led By Nicholas J Shaheeen, MD, MPH
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
2.1.4. Any residual dysplasia in tubular esophagus
18 or older years of age at time of consent.
Must not have
Known portal hypertension, visible esophageal varices, or history of esophageal varices.
5.2. Patients with IMC must be at low risk for recurrence, confirmed by EMR/ESD pathology results negative for: positive margin, >T1a stage, poorly differentiated carcinoma, and lymphovascular invasion.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
This trial is for adults who've had at least 2-3 unsuccessful radiofrequency ablations to treat Barrett's Esophagus with dysplasia or intestinal metaplasia. Candidates should not have used certain esophageal treatments before, must be in good health overall, and willing to follow the study plan.
What is being tested?
The NO FEAR-BE trial tests the C2 CryoBalloon Focal Ablation System's safety and effectiveness on patients whose Barrett's Esophagus hasn't improved after multiple radiofrequency ablations. It’s a single-group study without randomization.
What are the potential side effects?
Potential side effects may include discomfort or pain at the treatment site, risks associated with endoscopy like bleeding or infection, and possible damage to the esophagus such as tears or perforations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have abnormal cell growth in my esophagus.
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I am 18 years old or older.
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I have had at least 3 RFA treatments.
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I have areas of Barrett's esophagus larger than 1 cm.
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I have never had balloon or spray cryotherapy for my esophagus, but I may have had APC.
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My Barrett's esophagus extends at least 1 cm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have or had high blood pressure in the liver or swollen veins in my esophagus.
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My early-stage stomach cancer is at low risk of coming back, confirmed by specific test results.
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I have had abnormal findings like ulcers or masses seen in an endoscopy.
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My esophagus has a significant area affected after treatment.
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I have severe acid reflux diagnosed by a doctor.
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I have a fungal infection in my esophagus.
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My condition is limited to early changes in the upper part of my stomach.
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I do not have uncontrolled bleeding disorders.
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My esophageal cancer has not been treated yet.
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I cannot stop taking blood thinners as recommended for a high-risk procedure.
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I have untreated narrowings in my esophagus causing symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
Incidence of CryoBalloon-related serious adverse events
Percentage of all treated subjects with complete eradication of dysplasia (CED) within 12 months of enrollment
Secondary study objectives
Mean number of CryoBalloon ablation treatments required to achieve CED and CEIM by 12 months from enrollment date.
Pain
Mean pain score - Day 30
+16 more

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 Focal Ablation System (CbFAS) TreatmentExperimental Treatment1 Intervention
Subjects undergoing CbFAS treatment as part of their clinical care for their condition.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CryoBalloon Focal Ablation System
2016
N/A
~80

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,557 Previous Clinical Trials
4,298,499 Total Patients Enrolled
PENTAX of America, Inc.UNKNOWN
Johns Hopkins UniversityOTHER
2,327 Previous Clinical Trials
14,874,740 Total Patients Enrolled

Media Library

CryoBalloon Focal Ablation System (Cryoablation Device) Clinical Trial Eligibility Overview. Trial Name: NCT03554356 — N/A
Barrett's Esophagus Research Study Groups: Cryoballoon Focal Ablation System (CbFAS) Treatment
Barrett's Esophagus Clinical Trial 2023: CryoBalloon Focal Ablation System Highlights & Side Effects. Trial Name: NCT03554356 — N/A
CryoBalloon Focal Ablation System (Cryoablation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03554356 — N/A
~17 spots leftby Dec 2026
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