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Procedure
Radiofrequency ablation for Barrett's Esophagus
N/A
Waitlist Available
Led By Stuart J Spechler, MD
Research Sponsored by Dallas VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Barrett's esophagus
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week, 2 weeks, 4 weeks
Awards & highlights
Study Summary
This trial is studying how well radiofrequency ablation (RFA) works in treating patients with Barrett's esophagus (BE). RFA is a mainstay of treatment for patients who have BE with dysplasia, but it's unclear why Barrett's esophagus recurs after successful RFA treatment in approximately 1/3 of patients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week, 2 weeks, 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week, 2 weeks, 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the Percent of Mucosa Healed by Neosquamous Epithelium
Secondary outcome measures
Stem cells
Change in inflammatory cell infiltrate
Side effects data
From 2016 Phase 4 trial • 35 Patients • NCT024627209%
Phlebitis
3%
Pain in extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Varithena®
Radiofrequency Ablation
Trial Design
1Treatment groups
Experimental Treatment
Group I: Barrett's Esophagus TreatmentExperimental Treatment5 Interventions
All participants are in the treatment arm. Patients with Barrett's esophagus will undergo baseline surveillance endoscopy, be treated with radiofrequency ablation, and undergo follow up endoscopy 1, follow up endoscopy 2, and follow up endoscopy 3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Follow up endoscopy 3
2017
N/A
~10
Baseline surveillance endoscopy
2017
N/A
~10
Radiofrequency ablation
2011
Completed Phase 4
~2290
Follow up endoscopy 2
2017
N/A
~10
Follow up endoscopy 1
2017
N/A
~10
Find a Location
Who is running the clinical trial?
Dallas VA Medical CenterLead Sponsor
34 Previous Clinical Trials
4,827 Total Patients Enrolled
Stuart J Spechler, MDPrincipal InvestigatorBaylor Scott and White Research Institute
5 Previous Clinical Trials
555 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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