Observational Study of Anti-Reflux Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Torax Medical Incorporated
ClinicalTrials.gov Identifier:
NCT01624506
First received: June 18, 2012
Last updated: March 3, 2015
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


Enrollment: 734
Study Start Date: January 2010
Study Completion Date: January 2015
Primary Completion Date: January 2015 (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
Vienna, Austria
AKH Wien
Wien, Austria
Germany
MIC Klinik Berlin
Berlin, Germany
Knappschafts Krankenhaus Bottrop
Bottrop, Germany
Diako Bremen
Bremen, Germany
Krankenhaus Castrop Rauxel
Castrop Rauxel, Germany
Klinikum Forchheim
Forchheim, Germany
Krankenhaus Herne
Herne, Germany
Marien Krankenhaus
Kassel, Germany
Uniklinikum Koln
Koln, Germany
Arabella Klinik
Munchen, Germany
Ruppiner Kliniken
Neuruppin, Germany
Stadtkrankenhaus Schwabach
Schwabach, Germany
St. Rochus
Telgte, Germany
Ev. K Zweibrucken
Zweibrucken, Germany
Italy
Policlinico San Donato
Milan, Italy
United Kingdom
Reflux Centre
Birmingham, United Kingdom
Epsom and St. Helier Hospital
Epsom, United Kingdom
Royal Devon & Exeter Hospital
Exeter, United Kingdom
Spire Tunbridge Wells Hospital
Kent, United Kingdom
Weymouth Hospital
Weymouth, United Kingdom
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: March 3, 2015
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 29, 2015