Observational Study of Anti-Reflux Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Torax Medical Incorporated
Sponsor:
Information provided by (Responsible Party):
Torax Medical Incorporated
ClinicalTrials.gov Identifier:
NCT01624506
First received: June 18, 2012
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

The Anti-Reflux Surgical Study has been established to:

  • Collect data about anti-reflux surgical treatment options (magnetic sphincter augmentation and Fundoplication) in everyday clinical practice
  • Track the clinical course of patients from pre-operative assessment to three years post-surgery

Condition
GERD

Study Type: Observational
Official Title: Observational Study of Anti-Reflux Surgery: Clinical Experience With the LINX Reflux Management System and Fundoplication

Resource links provided by NLM:


Further study details as provided by Torax Medical Incorporated:

Primary Outcome Measures:
  • Collect data about anti-reflux surgical treatment options (LINX Reflux Management System and Fundoplication) in everyday clinical practice [ Time Frame: 3 years post-surgery ] [ Designated as safety issue: No ]
    Track the clinical course of patients from pre-operative assessment to three years post-surgery


Estimated Enrollment: 800
Study Start Date: January 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Magnetic Sphincter Augmentation
Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System
Fundoplication - advanced GERD
Patients treated with laparoscopic fundoplication who have one or more of the following: Large hernia (>3cm), Barrett's esophagus, motility disorder, Grade C or D esophagitis by LA Classification
Fundoplication - moderate GERD
Patients treated with laparoscopic fundoplication who do NOT have the following: Large hernia (>3cm), Barrett's esophagus, motility disorder, Grade C or D esophagitis by LA Classification

Detailed Description:

This study will track and monitor patients treated with either the magnetic sphincter augmentation or Fundoplication, making it the first Registry to collect data on both anti-reflux surgical options in the setting of everyday clinical experience.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing antireflux surgery for the treatment of GERD

Criteria

Inclusion Criteria:

  • Individuals treated with LINX Reflux Management System or Fundoplication
  • Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the Anti-Reflux Surgical Registry.
  • Individuals willing to complete questionnaires and comply with the three years of follow-up.

Exclusion Criteria:

  • Known circumstances that would make it unlikely for an individual to complete the three year follow-up (e.g. life expectancy <3 years)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624506

Locations
Austria
Herz Jesu Krankenhaus Recruiting
Vienna, Austria
Contact: Zacherl       Johannes.Zacherl@kh-herzjesu.at   
Principal Investigator: Johannes Zacherl         
AKH Wien Recruiting
Wien, Austria
Contact: Riegler       franz.riegler@meduniwien.ac.at   
Principal Investigator: Martin Riegler         
Germany
MIC Klinik Berlin Recruiting
Berlin, Germany
Contact: Susewind       m.susewind@mic-berlin.de   
Principal Investigator: Martin Susewind         
Knappschafts Krankenhaus Bottrop Recruiting
Bottrop, Germany
Contact: Peitgen       klaus.peitgen@kk-bottrop.de   
Principal Investigator: Klaus Peitgen         
Diako Bremen Recruiting
Bremen, Germany
Contact: Freys       s.freys@diako-bremen.de   
Principal Investigator: Stephen Freys         
Krankenhaus Castrop Rauxel Recruiting
Castrop Rauxel, Germany
Contact: Schulz       h.g.schulz@evk-castrop-rauxel.de   
Principal Investigator: Henning Schulz         
Klinikum Forchheim Recruiting
Forchheim, Germany
Contact: Drummer       Bernhard.Drummer@klinikum-forchheim.de   
Principal Investigator: Bernhard Drummer         
Krankenhaus Herne Recruiting
Herne, Germany
Contact: Kemen       m.kemen@evk-herne.de   
Principal Investigator: Matthias Kemen         
Marien Krankenhaus Recruiting
Kassel, Germany
Contact: Heimbucher       J.Heimbucher@marienkrankenhaus-kassel.de   
Principal Investigator: Johannes Heimbucher         
Uniklinikum Koln Recruiting
Koln, Germany
Contact: Holscher       amulf.hoelscher@uk-koeln.de   
Principal Investigator: Arnulf Holscher         
Arabella Klinik Recruiting
Munchen, Germany
Contact: Merkle       merkle@viszera.de   
Principal Investigator: Richard Merkle         
Ruppiner Kliniken Recruiting
Neuruppin, Germany
Contact: Kujajewski       o.kujajewski@ruppiner-kliniken.de   
Principal Investigator: Ruppiner Kujajewski         
Stadtkrankenhaus Schwabach Recruiting
Schwabach, Germany
Contact: Horbach       THorbach@Schoen-Kliniken.de   
Principal Investigator: Thomas Horbach         
St. Rochus Recruiting
Telgte, Germany
Contact: Konermann       cleckon@t-online.de   
Principal Investigator: Christoph Konermann         
Ev. K Zweibrucken Recruiting
Zweibrucken, Germany
Contact: Birk       dr.d.birk@gmail.com   
Principal Investigator: Dieter Birk         
Italy
Policlinico San Donato Recruiting
Milan, Italy
Contact: Luigi Bonavina, Prof, med       luigi.bonavina@grupposandonato.it   
Contact: Greta Saino, MD         
Principal Investigator: Luigi Bonavina         
United Kingdom
Reflux Centre Recruiting
Birmingham, United Kingdom
Contact: Ashton       david.ashton@healthierweight.co.uk   
Principal Investigator: David Ashton         
Epsom and St. Helier Hospital Recruiting
Epsom, United Kingdom
Contact: Nehra       dnehra@doctors.org.uk   
Principal Investigator: Dhiren Nehra         
Royal Devon & Exeter Hospital Recruiting
Exeter, United Kingdom
Contact: Wajed       saj.wajed@nhs.net   
Principal Investigator: Saj Wajed         
Spire Tunbridge Wells Hospital Recruiting
Kent, United Kingdom
Contact: Maiden       laurence.maiden@nhs.net   
Principal Investigator: Laurence Maiden         
Weymouth Hospital Recruiting
Weymouth, United Kingdom
Contact: Hashemi       majid.hashemi@btopenworld.com   
Principal Investigator: Majid Hashemi         
Sponsors and Collaborators
Torax Medical Incorporated
  More Information

No publications provided

Responsible Party: Torax Medical Incorporated
ClinicalTrials.gov Identifier: NCT01624506     History of Changes
Other Study ID Numbers: 2776
Study First Received: June 18, 2012
Last Updated: September 12, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Torax Medical Incorporated:
GERD
Fundoplication
Magnetic Sphincter Augmentation

ClinicalTrials.gov processed this record on October 30, 2014