Observational Study of Anti-Reflux Surgery

This study is currently recruiting participants.
Verified November 2013 by Torax Medical Incorporated
Sponsor:
Information provided by (Responsible Party):
Torax Medical Incorporated
ClinicalTrials.gov Identifier:
NCT01624506
First received: June 18, 2012
Last updated: November 26, 2013
Last verified: November 2013
  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

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

Locations
Austria
Krankenhaus Hallein Recruiting
Hallein, Austria
Contact: Miller       karl.miller@kh-hallein.at   
Principal Investigator: Miller         
Medlzinlesche Universitat Wien Recruiting
Wien, Austria
Contact: Riegler       franz.riegler@meduniwien.ac.at   
Principal Investigator: Riegler         
Germany
Knappschaftskranekenhaus Recruiting
Bottrop, Germany
Contact: Peltgen       klaus.peltgen@kk-bottrop.de   
Principal Investigator: Peltgen         
Ev Castrop Rauxel Recruiting
Castrop Rauxel, Germany
Contact: Schulz       h.g.schulz@evk-castrop-rauxel.de   
Principal Investigator: Schulz         
Klinimum Forchheim Recruiting
Forchheim, Germany
Contact: Drummer       Bernhard.Drummer@klinikum-forchheim.de   
Principal Investigator: Drummer         
Frankfurter Diakone-Kliniken Markus-Kranhenhaus Recruiting
Frankfurt, Germany
Contact: Fuchs       karl-hermann.fuchs@fdk.info   
Principal Investigator: Fuchs         
Kllnlkum Friedrichschafen Recruiting
Friedrichshafen, Germany
Contact: Schafer       schaeferfritz@gmx.net   
Principal Investigator: Schafer         
Dle Evangellsche Krankenhausgemelnschaft Herne I Castrop-Rauxel Recruiting
Herne, Germany
Contact: Kemen       m.kemen@evk-herne.de   
Principal Investigator: Kemen         
Universltatskllnik Koln Allgemeln-, Vlazeral-und Tumorchlrurgle Recruiting
Koln, Germany
Contact: Holscher       amulf.hoelscher@uk-koeln.de   
Principal Investigator: Holscher         
Medlzinlsches Kiompetenzzentrum Recruiting
Munchen, Germany
Contact: Merkle       merkle@viszera.de   
Principal Investigator: Merkle         
Rupplner Kliniken Recruiting
Neuruppin, Germany
Contact: Buthut       t.buthut@ruppiner-kliniken.de   
Principal Investigator: Buthut         
Stadtkrankenhaus Schwabach Recruiting
Schwabach, Germany
Contact: Horbach       thomas.horbach@khsc.de   
Principal Investigator: Horbach         
Italy
San Donato Recruiting
Milan, Italy
Contact: Luigi Bonavina, Prof, med       luigi.bonavina@unimi.it   
Contact: Greta Saino, MD         
United Kingdom
Albyn Hosapital Recruiting
Aberdeen, United Kingdom
Contact: Park       Ken.Park@aberdeensurgical.co.uk   
Principal Investigator: Park         
Reflux Centre Recruiting
Birmingham, United Kingdom
Contact: Ashton       david.ashton@healthierweight.co.uk   
Principal Investigator: Ashton         
Royal Devon & Exeter Recruiting
Exeter, United Kingdom
Contact: Wajed       Sai.wajed@nhs.net   
Principal Investigator: Wajed         
Spire Tunbridge Wells Hospital Recruiting
Kent, United Kingdom
Contact: Maiden       laurence.maiden@nhs.net   
Principal Investigator: Maiden         
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: November 26, 2013
Health Authority: Local ethic committees: Germany

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

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 23, 2014