GERDNCT01624506
Observational Study of Anti-Reflux Surgery
An observational study of GERD and Gastroesophageal Reflux, run by Torax Medical Incorporated at 21 sites in 4 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD, Gastroesophageal Reflux, Gastro Esophageal Reflux
- How many people
- 760 participants
- Where
- 21 sitesin 4 countries
- Study dates
- Jan 2010to Jul 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing antireflux surgery for the treatment of gastroesophageal reflux disease (GERD)
Who may be able to join
- 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.
Who cannot join
- Known circumstances that would make it unlikely for an individual to complete the three year follow-up (e.g. life expectancy <3 years)
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
Germany13 sites
MIC Klinik Berlin
Berlin
Knappschafts Krankenhaus Bottrop
Bottrop
Diako Bremen
Bremen
Krankenhaus Castrop Rauxel
Castrop-Rauxel
Uniklinikum Koln
Cologne
Klinikum Forchheim
Forchheim
Krankenhaus Herne
Herne
Marien Krankenhaus
Kassel
Arabella Klinik
München
Ruppiner Kliniken
Neuruppin
Stadtkrankenhaus Schwabach
Schwabach
St. Rochus
Telgte
Ev. K Zweibrucken
Zweibrücken
United Kingdom5 sites
Reflux Centre
Birmingham
Epsom and St. Helier Hospital
Epsom
Royal Devon & Exeter Hospital
Exeter
Spire Tunbridge Wells Hospital
Royal Tunbridge Wells
Weymouth Hospital
Weymouth
About this study
Official title: Observational Study of Anti-Reflux Surgery: Clinical Experience With the LINX Reflux Management System and Fundoplication
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
Read the 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.
- Conditions
- GERD, Gastroesophageal Reflux, Gastro Esophageal Reflux
- Keywords
- Gastroesophageal Reflux Disease, Fundoplication, Magnetic Sphincter Augmentation, Proton Pump Inhibitors, GERD, PPI, MSA
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Sphincter Augmentation | Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System | |
| Fundoplication | Patients treated with laparoscopic fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJan 2010
- Primary completionJan 2015
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GERDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 760 participants (actual)
Sponsor and investigators
- Lead sponsor
- Torax Medical Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624506
- Sponsor's protocol ID
- 2776
- Status last verified
- May 2021
- First submitted
- 18 Jun 2012
- Last updated
- 8 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bonavina L, Horbach T, Schoppmann SF, DeMarchi J. Three-year clinical experience with magnetic sphincter augmentation and laparoscopic fundoplication. Surg Endosc. 2021 Jul;35(7):3449-3458. doi: 10.1007/s00464-020-07792-1. Epub 2020 Jul 16.
PubMed 32676727Riegler M, Schoppman SF, Bonavina L, Ashton D, Horbach T, Kemen M. Magnetic sphincter augmentation and fundoplication for GERD in clinical practice: one-year results of a multicenter, prospective observational study. Surg Endosc. 2015 May;29(5):1123-9. doi: 10.1007/s00464-014-3772-7. Epub 2014 Aug 30.
PubMed 25171881
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Anti-Reflux Surgery: Clinical Experience With the LINX Reflux Management System and Fundoplication
- ClinicalTrials.gov ID
- NCT01624506
- Acronym / sponsor ID
- 2776
- Conditions
- GERD, Gastroesophageal Reflux, Gastro Esophageal Reflux
- Keywords
- Gastroesophageal Reflux Disease, Fundoplication, Magnetic Sphincter Augmentation, Proton Pump Inhibitors, GERD, PPI, MSA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 760 participants (actual)
- Lead sponsor
- Torax Medical IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 20 Jun 2012 (estimated)
- Results
- Posted 8 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic Sphincter Augmentation | – | –Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System |
| Fundoplication | – | –Patients treated with laparoscopic fundoplication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing antireflux surgery for the treatment of gastroesophageal reflux disease (GERD)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Known circumstances that would make it unlikely for an individual to complete the three year follow-up (e.g. life expectancy <3 years)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL)
Time frame: 3 years post-surgery
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32676727Bonavina L, Horbach T, Schoppmann SF, DeMarchi J. Three-year clinical experience with magnetic sphincter augmentation and laparoscopic fundoplication. Surg Endosc. 2021 Jul;35(7):3449-3458. doi: 10.1007/s00464-020-07792-1. Epub 2020 Jul 16.
- Derived from this study: PubMed 25171881Riegler M, Schoppman SF, Bonavina L, Ashton D, Horbach T, Kemen M. Magnetic sphincter augmentation and fundoplication for GERD in clinical practice: one-year results of a multicenter, prospective observational study. Surg Endosc. 2015 May;29(5):1123-9. doi: 10.1007/s00464-014-3772-7. Epub 2014 Aug 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GERD and Gastroesophageal Reflux, run by Torax Medical Incorporated at 21 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Germany, United Kingdom, Austria, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL) (time frame: 3 years post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01624506, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.