Trial record 1 of 1 for:    NCT01624506
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Observational Study of Anti-Reflux Surgery

This study is currently recruiting participants. (see Contacts and Locations)
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
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
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 July 20, 2014