Gastroesophageal Reflux Clinical Trial
Official title:
Observational Study of Anti-Reflux Surgery: Clinical Experience With the LINX Reflux Management System and Fundoplication
| NCT number | NCT01624506 |
| Other study ID # | 2776 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2010 |
| Est. completion date | July 2018 |
| Verified date | May 2021 |
| Source | Torax Medical Incorporated |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 760 |
| Est. completion date | July 2018 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Herz Jesu Krankenhaus | Vienna | |
| Austria | AKH Wien | Wien | |
| 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 | |
| Italy | Policlinico San Donato | Milan | |
| 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 | Tunbridge Wells | |
| United Kingdom | Weymouth Hospital | Weymouth |
| Lead Sponsor | Collaborator |
|---|---|
| Torax Medical Incorporated |
Austria, Germany, Italy, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL) | Gastroesophageal Reflux Disease Health Related Quality of Life Outcomes (GERD-HRQL) Total scores range from 0-50 (min/max) 10 questions total, each rating 0-5 (min/max) Lower is better; higher is worse | 3 years post-surgery |
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