Observational Study of Anti-Reflux Surgery
This study is currently recruiting participants.
Verified June 2012 by Torax Medical Incorporated
Sponsor:
Torax Medical Incorporated
Information provided by (Responsible Party):
Torax Medical Incorporated
ClinicalTrials.gov Identifier:
NCT01624506
First received: June 18, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
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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:
| 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: | June 18, 2012 |
| 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 May 23, 2013