NCT02793479

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

3.8 years

First QC Date

June 1, 2016

Last Update Submit

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

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

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: 16360414BACKGROUND
  • Fleischer 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: 20405211BACKGROUND
  • Fleischer 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

Barrett EsophagusGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesEsophageal Motility DisordersDeglutition Disorders

Study Officials

  • Sebastian F Schoppmann, MD

    Medical University of Vienna

    STUDY DIRECTOR

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

Locations