Radiofrequency Ablation in Patients With Barrett's Esophagus
RABE
National Registry for Radiofrequency Ablation in Patients With Barrett's Esophagus
1 other identifier
observational
500
1 country
1
Brief Summary
The aim of this study is to establish a nationwide registry to collect data regarding the treatment of Barrett's Esophagus (BE) with radiofrequency ablation. The objective of this registry is to increase the number of data and therefore obtain a raise of quality assurance and improve outcome and patient security. Furthermore to provide participating physicians information and experience for treatment details in the therapy of BE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 8, 2016
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJuly 5, 2019
July 1, 2019
3.8 years
June 1, 2016
July 2, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Number of patients treated with Radiofrequency Ablation for Barrett's Esophagus in Austria
5 years
Elimination Rate of Barrett's Esophagus in the study population
5 years
Study Arms (1)
BE
Patients presenting Barrett's Esophagus as a complication of a gastroesophageal reflux disease.
Eligibility Criteria
Each center should define a system for identification and eligibility screening of patients.
You may qualify if:
- Patients with a histological confirmed BE, who give their informed consent for participation in an anonymized registry.
You may not qualify if:
- Patients, who do not give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Matthias Pairederlead
- Medtronic - MITGcollaborator
Study Sites (1)
Medical University of Vienna
Vienna, 1090, Austria
Related Publications (3)
Chandrasoma P, Makarewicz K, Wickramasinghe K, Ma Y, Demeester T. A proposal for a new validated histological definition of the gastroesophageal junction. Hum Pathol. 2006 Jan;37(1):40-7. doi: 10.1016/j.humpath.2005.09.019. Epub 2005 Nov 28.
PMID: 16360414BACKGROUNDFleischer DE, Odze R, Overholt BF, Carroll J, Chang KJ, Das A, Goldblum J, Miller D, Lightdale CJ, Peters J, Rothstein R, Sharma VK, Smith D, Velanovich V, Wolfsen H, Triadafilopoulos G. The case for endoscopic treatment of non-dysplastic and low-grade dysplastic Barrett's esophagus. Dig Dis Sci. 2010 Jul;55(7):1918-31. doi: 10.1007/s10620-010-1218-1. Epub 2010 Apr 20.
PMID: 20405211BACKGROUNDFleischer DE, Overholt BF, Sharma VK, Reymunde A, Kimmey MB, Chuttani R, Chang KJ, Muthasamy R, Lightdale CJ, Santiago N, Pleskow DK, Dean PJ, Wang KK. Endoscopic radiofrequency ablation for Barrett's esophagus: 5-year outcomes from a prospective multicenter trial. Endoscopy. 2010 Oct;42(10):781-9. doi: 10.1055/s-0030-1255779. Epub 2010 Sep 20.
PMID: 20857372BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sebastian F Schoppmann, MD
Medical University of Vienna
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
June 1, 2016
First Posted
June 8, 2016
Study Start
March 1, 2017
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
July 5, 2019
Record last verified: 2019-07