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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
NO FEAR-BE Trial 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.Check my eligibility
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.See study design
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.
NO FEAR-BE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
NO FEAR-BE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
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 moreNO FEAR-BE 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
1,508 Previous Clinical Trials
4,190,972 Total Patients Enrolled
PENTAX of America, Inc.UNKNOWN
Johns Hopkins UniversityOTHER
2,266 Previous Clinical Trials
14,837,427 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had high blood pressure in the liver or swollen veins in my esophagus.My esophagus was narrow but has been widened to at least 15mm.I have had abnormal findings like ulcers or masses seen in an endoscopy.My esophagus has a significant area affected after treatment.I have severe acid reflux diagnosed by a doctor.I have a fungal infection in my esophagus.I have abnormal cell growth in my esophagus.I am 18 years old or older.My condition is limited to early changes in the upper part of my stomach.I have Barrett's esophagus with confirmed low or high-grade dysplasia, or treated early-stage cancer with low risk of coming back.I've had at least 2 RFA treatments for BE with less than 50% success.I have severe health issues that make endoscopy risky and may live less than 2 years.I have had esophageal surgery, but not a simple nissen fundoplication.My early-stage stomach cancer is at low risk of coming back, confirmed by specific test results.I had a specific stomach or esophagus procedure less than 6 weeks ago.I have had RFA treatment before.You have multiple health problems or are generally not in good health, which could put you at risk if you participate in the trial.I do not have uncontrolled bleeding disorders.I have had at least 3 RFA treatments.My esophageal cancer has not been treated yet.I have areas of Barrett's esophagus larger than 1 cm.I cannot stop taking blood thinners as recommended for a high-risk procedure.I am open to trying a different standard treatment for my condition.I have never had balloon or spray cryotherapy for my esophagus, but I may have had APC.My Barrett's esophagus extends at least 1 cm.I have untreated narrowings in my esophagus causing symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Cryoballoon Focal Ablation System (CbFAS) Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applicants still being accepted for this research endeavor?
"Clinicaltrials.gov affirms that this trial is still on the hunt for participants, with recruitment having started back on September 4th 2018 and last updated November 28th 2022."
Answered by AI
What key goals is this investigation hoping to achieve?
"The central purpose of this 12-month trial is to determine the rate of complete eradication of all intestinal metaplasia (CEIM). Secondary objectives include a survival curve analysis that tracks time to recurrence, progression rate, and time to progression."
Answered by AI
Are there any hospitals that are actively conducting this experiment?
"The medical study is running in 12 centres, such as Mount Sinai's Icahn School of Medicine (New york), University of Alabama at Birmingham (Birmingham) and University Hospitals Cleveland Medical Center (Cleveland). There are 9 other sites also participating."
Answered by AI
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