Gastroesophageal Reflux Disease (GERD)NCT01940185
A Post-Approval Study of the LINX® Reflux Management System
An observational study of Gastroesophageal Reflux Disease (GERD), run by Torax Medical Incorporated at 19 sites in United States.
Trial summary
A Post-Approval Study of the LINX® Reflux Management System in a prospective, multicenter, single-arm study, with patients as their own control to monitor the safety and efficacy of the LINX implant procedure and device in a post-approval environment to supplement existing safety and efficacy data. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- What is being tested?
- LINX device
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 19 sitesUnited States
- Study dates
- 30 Jun 2012to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux
Who may be able to join
- Patient is a candidate for treatment with the LINX Reflux Management System
- Patient has provided written informed consent for participation in the post-approval study.
- Patient has indicated a willingness to comply with study requirements and the follow-up schedule and assessments.
- Patient has been diagnosed with GERD as defined by abnormal pH testing.
- Patient continues to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.
Who cannot join
- Patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
- Known circumstances that would make it unlikely for the patient to complete follow-up through 60 months.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Albany Surgical
Albany, Georgia, 31701
Virginia Hospital Center
Arlington, Virginia, 22205
Esophageal Institute of Atlanta, PC.
Atlanta, Georgia, 30309
Bingham Memorial Hospital
Blackfoot, Idaho, 83221
Beth Israel
Boston, Massachusetts, 02215
University Hospitals Cleveland Medical Center - Geauga
Cleveland, Ohio, 44106
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Cuyuna Regional Medical Center
Crosby, Minnesota, 56441
Swedish Medical Center/SurgOne
Englewood, Colorado, 80110
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
VIP Surg PLLC
Las Vegas, Nevada, 89113
Keck Medical Center of Univeristy of Southern California
Los Angeles, California, 90033
Froedtert and Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Knox Community Hospital
Mount Vernon, Ohio, 43050
Allegheny Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
The Oregon Clinic
Portland, Oregon, 97213
University of California San Diego
San Diego, California, 92103
Candler Hospital
Savannah, Georgia, 31406
Swedish Medical Center
Seattle, Washington, 98104
About this study
A Post-Approval Study of the LINX® Reflux Management System in a prospective, multicenter, single-arm study, with patients as their own control to monitor the safety and efficacy of the LINX implant procedure and device in a post-approval environment to supplement existing safety and efficacy data.
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Being tested
- LINX device
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LINX deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| LINX device | Patients implanted with the LINX® Reflux Management System. Receives: Device: LINX device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of total GERD-HRQL score
Successful reduction of ≥ 50% in the total GERD-HRQL as compared to baseline.
Measured: 6 months, 12 months, and annually to 60 months
Serious, device-related adverse events
Reporting all serious device-related adverse events and summarizing by the number of events, the number of study patients with event, and the percent of study patients implanted with event. No formal statistical hypothesis tests will be conducted.
Measured: 60 months
Secondary outcomes (3)
Related Adverse Events
Incidence rate of of device- and/or procedure-related adverse events
Measured: 120 months
pH Measurements
Reduction from baseline in Total % time esophageal pH<4
Measured: The secondary measurements will be evaluated at yearly interval to 120 months (esophageal pH not conducted at 72, 84, 96 and 108 months)
Reduction of Symptoms
Reduction from baseline on Foregut Symptom Questionnaire (frequency and severity of heartburn and regurgitation, extra-esophageal symptoms and side effect profile). No formal statistical hypothesis tests will be conducted. Any statistical analyses will be primarily descriptive.
Measured: The secondary measurements will be evaluated at yearly interval to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study start30 Jun 2012
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 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
- NCT01940185
- Sponsor's protocol ID
- 3545
- Status last verified
- Jan 2024
- First submitted
- 6 Sep 2013
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Louie BE, Smith CD, Smith CC, Bell RCW, Gillian GK, Mandel JS, Perry KA, Birkenhagen WK, Taiganides PA, Dunst CM, McCollister HM, Lipham JC, Khaitan LK, Tsuda ST, Jobe BA, Kothari SN, Gould JC. Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study. Ann Surg. 2019 Aug;270(2):302-308. doi: 10.1097/SLA.0000000000002789.
PubMed 29697454
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Approval Study of the LINX® Reflux Management System
- ClinicalTrials.gov ID
- NCT01940185
- Acronym / sponsor ID
- 3545
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Torax Medical IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2012 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 12 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Post-Approval Study of the LINX® Reflux Management System in a prospective, multicenter, single-arm study, with patients as their own control to monitor the safety and efficacy of the LINX implant procedure and device in a post-approval environment to supplement existing safety and efficacy data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LINX device | – | Device: LINX devicePatients implanted with the LINX® Reflux Management System. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux
Key inclusion criteria (5 listed)
- Patient is a candidate for treatment with the LINX Reflux Management System
- Patient has provided written informed consent for participation in the post-approval study.
- Patient has indicated a willingness to comply with study requirements and the follow-up schedule and assessments.
- Patient has been diagnosed with GERD as defined by abnormal pH testing.
- Patient continues to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.
Key exclusion criteria (2 listed)
- Patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
- Known circumstances that would make it unlikely for the patient to complete follow-up through 60 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LINX device | Device | LINX device |
Primary outcome
Reduction of total GERD-HRQL score
Time frame: 6 months, 12 months, and annually to 60 months
Successful reduction of ≥ 50% in the total GERD-HRQL as compared to baseline.
Serious, device-related adverse events
Time frame: 60 months
Reporting all serious device-related adverse events and summarizing by the number of events, the number of study patients with event, and the percent of study patients implanted with event. No formal statistical hypothesis tests will be conducted.
3 secondary outcomes
Related Adverse Events
Time frame: 120 months
pH Measurements
Time frame: The secondary measurements will be evaluated at yearly interval to 120 months (esophageal pH not conducted at 72, 84, 96 and 108 months)
Reduction of Symptoms
Time frame: The secondary measurements will be evaluated at yearly interval to 120 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Results publication: PubMed 29697454Louie BE, Smith CD, Smith CC, Bell RCW, Gillian GK, Mandel JS, Perry KA, Birkenhagen WK, Taiganides PA, Dunst CM, McCollister HM, Lipham JC, Khaitan LK, Tsuda ST, Jobe BA, Kothari SN, Gould JC. Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study. Ann Surg. 2019 Aug;270(2):302-308. doi: 10.1097/SLA.0000000000002789.
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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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease (GERD), run by Torax Medical Incorporated at 19 sites in United States.
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 5 inclusion and 2 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 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction of total GERD-HRQL score (time frame: 6 months, 12 months, and annually to 60 months). The study lists 2 primary outcomes in all. 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 NCT01940185, which also lists 1 linked publication.
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 5 Jan 2024.