Gastroesophageal RefluxNCT00776997
LINX Reflux Management System Clinical Study Protocol
A study testing Magnetic Sphincter Augmentation in people with Gastroesophageal Reflux, run by Torax Medical Incorporated at 14 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the safety and effectiveness of the LINX Reflux Management System in the treatment of Gastroesophageal Reflux Disease (GERD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Magnetic Sphincter Augmentation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Nov 2008to Sep 2011
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be at least 18 years of age and at least the minimum Age of Majority according to applicable State or Country Law and must be less than 75 years of age, with a life expectancy > 3 years
- Subject is a suitable surgical candidate, i.e. is able to undergo general anesthesia and laparoscopic surgery
- Documented typical symptoms of gastroesophageal reflux disease (GERD) for longer than 6 months (regurgitation or heartburn which is defined as a burning epigastic or substernal pain which responds to acid neutralization or suppression)
- Patient requires daily proton pump inhibitor or other anti-reflux drug therapy
- Total Distal Ambulatory Esophageal pH must meet the following criteria: pH< 4 for ≥ 4.5% of the time Note: Subjects shall have discontinued any GERD medications for at least 7 days prior to testing.
- Subjects with symptomatic improvement on proton-pump inhibitor (PPI) therapy demonstrated by a GERD-Health-Related Quality of Life (GERD-HRQL) score of ≤ 10 on proton-pump inhibitors and ≥ 15 off PPIs, or subjects with a ≥ 6 point improvement when comparing their on PPI and off PPI GERD-HRQL score
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- GERD symptoms, in absence of PPI therapy (minimum 7 days)
- If the subject is of child bearing potential must have a negative pregnancy test within one week prior to implant and must agree to use effective means of birth control during the course of the study
- Subject is willing and able to cooperate with follow-up examinations
- Subject has been informed of the study procedures and the treatment and has signed an informed consent form
Who cannot join
- The procedure is an emergency procedure
- Currently being treated with another investigational drug or investigational device
- History of gastroesophageal surgery, anti-reflux procedures, or gastroesophageal/gastric cancer
- Any previous endoscopic anti-reflux intervention for GERD
- Suspected or confirmed esophageal or gastric cancer
- Any size hiatal hernia >3cm as determined by endoscopy
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- Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences
- Esophagitis - Grade C or D (LA Classification)
- Body Mass Index (BMI)>35
- Symptoms of dysphagia more than once per week within the last 3 months.
- Diagnosed with Scleroderma
- Diagnosed with an esophageal motility disorder such as but not limited to Achalasia, Nutcracker Esophagus, or Diffuse Esophageal Spasm or Hypertensive LES
- Subject has a history of or known esophageal stricture or gross esophageal anatomic abnormalities (Schatzki's ring, obstructive lesions, etc.)
- Subject has esophageal or gastric varices
- Subject has history of or known Barrett's esophagus
- Cannot understand trial requirements or is unable to comply with follow-up schedule
- Pregnant or nursing, or plans to become pregnant during the course of the study
- Medical illness (i.e. congestive heart failure) that may cause the subject to be non-compliant with or able to meet the protocol requirements or is associated with limited life expectancy (i.e. less than 3 years)
- Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that exhibit depression that are on appropriate medication(s) are allowable.
- Suspected or known allergies to titanium, stainless steel, nickel or ferrous materials
- Subject has an electrical implant or metallic, abdominal implants
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701
The Ohio State University Medical Center / Center for Minimally Invasive Surgery
Columbus, Ohio, 43210
Mayo Clinic
Jacksonville, Florida, 32224
Gundersen Lutheran Clinic
La Crosse, Wisconsin, 54601
USC Keck School of Medicine
Los Angeles, California, 90033
Abbott Northwestern Hospital/MNGI
Minneapolis, Minnesota, 55407
Knox Community Hospital
Mount Vernon, Ohio, 43050
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Legacy Health System
Portland, Oregon, 97210
University of Rochester Medical Center
Rochester, New York, 14642
University of California - San Diego
San Diego, California, 92103
University of Washington Medical Center
Seattle, Washington, 98195
Washington University - Division of Gastroenterology
St Louis, Missouri, 63110
About this study
The purpose of the study is to evaluate the safety and effectiveness of the LINX Reflux Management System in the treatment of Gastroesophageal Reflux Disease (GERD).
Read the detailed description
At present, the primary alternative for GERD patients with an incomplete symptomatic response to proton-pump inhibitors (PPIs) is laparoscopic Nissen fundoplication. This surgical procedure continues to be the prevalent non-medical treatment option for GERD patients, despite several important limitations. First, it is a very traumatic procedure, requiring portions of the stomach to be dissected and then wrapped around the tubular esophagus, creating permanent anatomic alterations. Secondly, it can create significant side effects, such as gas bloat syndrome, the inability to belch and the inability to vomit.
The intent of the LINX System is to allow a surgeon, using existing laparoscopic techniques and instruments, to augment a weak LES and restore the defective barrier at the gastroesophageal junction (GEJ). This defect of the GEJ is the source of abnormal reflux. The LINX device is an expandable string of individual titanium beads with magnetic cores. The device is laparoscopically placed as a ring around the lower esophageal sphincter. The magnetic attraction of the beads augments the esophageal sphincter's ability to resist gastric pressures that cause reflux. At rest, the LINX device encircles the sphincter with each bead resting against an adjacent bead, to avoid compression of the tubular esophagus. When swallowing, higher pressures are created, allowing the magnetic bond between beads to break, and the LINX implant to expand radially. This serves to preserve swallow and other physiologic functions, such as belching and vomiting, and avoids the side effect of post-prandial bloating. The device can be placed with minimal dissection, preserving anatomy, and is also removable, if necessary. This provides important benefits as it preserves the native anatomy, unlike the Nissen procedure.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Magnetic Sphincter Augmentation
- Keywords
- Gastroesophageal Reflux
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Sphincter AugmentationDevice
Also called LINX Reflux Management System, Magnetic Esophageal Sphincter
The area of the lower esophageal sphincter (LES) is accessed using a standard laparoscopic approach. The tubular esophagus, in the area of the LES, is sized and the appropriately sized sphincter augmentation device is placed circumferentially around the esophagus in the area of the LES. After confirming proper placement, the ends of the device are secured. At this point, the implant procedure is complete, laparoscopic instruments are withdrawn and access points are closed.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Sphincter Augmentation | Other | Single-arm study: all subjects were treated with magnetic sphincter augmentation. A subject's baseline measurements prior to sphincter augmentation were compared to post-sphincter augmentation measurements. Subjects served as their own control. Receives: Device: Magnetic Sphincter Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Occurrence for Device and Procedure Related Serious Adverse Events (SAEs).
SAE was defined as any untoward medical occurrence, whether related to the study device or procedure or not, that meets one or more of the following criteria:
- Results in death
- Is life-threatening
- Requires subject hospitalization > 24 hours
- Requires prolongation of an existing hospitalization
- Results in persistent or significant disability/incapacity
- Results in fetal distress, fetal death, or a congenital anomaly or birth defect
- Requires intervention to prevent permanent impairment or damage.
Outcome measure reports number of subjects with reported events.
Measured: through 24 months
Normalization of Esophageal Acid Exposure Time or Reduced Total Acid Exposure Time of at Least 50% Compared to the Subject's Baseline Measurement by Esophageal pH Testing.
The analysis cohort for the primary efficacy analysis was the treated population which includes all implanted subjects and was determined through esophageal pH testing.
Measured: 12 Months
Secondary outcomes (2)
At Least a 50% Reduction in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Total Score Compared to Baseline
Measured: 12 months
Average Daily Proton-pump Inhibitor (PPI) Dosage Reduced by at Least 50% Compared to Baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2010
- Study completionSep 2011
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 Gastroesophageal RefluxStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT00776997
- Sponsor's protocol ID
- 1802
- Status last verified
- Mar 2018
- First submitted
- 20 Oct 2008
- Last updated
- 4 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ganz RA, Edmundowicz SA, Taiganides PA, Lipham JC, Smith CD, DeVault KR, Horgan S, Jacobsen G, Luketich JD, Smith CC, Schlack-Haerer SC, Kothari SN, Dunst CM, Watson TJ, Peters J, Oelschlager BK, Perry KA, Melvin S, Bemelman WA, Smout AJ, Dunn D. Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. Clin Gastroenterol Hepatol. 2016 May;14(5):671-7. doi: 10.1016/j.cgh.2015.05.028. Epub 2015 Jun 2.
PubMed 26044316Ganz RA, Peters JH, Horgan S, Bemelman WA, Dunst CM, Edmundowicz SA, Lipham JC, Luketich JD, Melvin WS, Oelschlager BK, Schlack-Haerer SC, Smith CD, Smith CC, Dunn D, Taiganides PA. Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med. 2013 Feb 21;368(8):719-27. doi: 10.1056/NEJMoa1205544.
PubMed 23425164
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LINX Reflux Management System Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT00776997
- Acronym / sponsor ID
- 1802
- Conditions
- Gastroesophageal Reflux
- Keywords
- Gastroesophageal Reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Torax Medical IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Posted 13 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety and effectiveness of the LINX Reflux Management System in the treatment of Gastroesophageal Reflux Disease (GERD).
Detailed description
At present, the primary alternative for GERD patients with an incomplete symptomatic response to proton-pump inhibitors (PPIs) is laparoscopic Nissen fundoplication. This surgical procedure continues to be the prevalent non-medical treatment option for GERD patients, despite several important limitations. First, it is a very traumatic procedure, requiring portions of the stomach to be dissected and then wrapped around the tubular esophagus, creating permanent anatomic alterations. Secondly, it can create significant side effects, such as gas bloat syndrome, the inability to belch and the inability to vomit.
The intent of the LINX System is to allow a surgeon, using existing laparoscopic techniques and instruments, to augment a weak LES and restore the defective barrier at the gastroesophageal junction (GEJ). This defect of the GEJ is the source of abnormal reflux. The LINX device is an expandable string of individual titanium beads with magnetic cores. The device is laparoscopically placed as a ring around the lower esophageal sphincter. The magnetic attraction of the beads augments the esophageal sphincter's ability to resist gastric pressures that cause reflux. At rest, the LINX device encircles the sphincter with each bead resting against an adjacent bead, to avoid compression of the tubular esophagus. When swallowing, higher pressures are created, allowing the magnetic bond between beads to break, and the LINX implant to expand radially. This serves to preserve swallow and other physiologic functions, such as belching and vomiting, and avoids the side effect of post-prandial bloating. The device can be placed with minimal dissection, preserving anatomy, and is also removable, if necessary. This provides important benefits as it preserves the native anatomy, unlike the Nissen procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic Sphincter Augmentation | Other | Device: Magnetic Sphincter AugmentationSingle-arm study: all subjects were treated with magnetic sphincter augmentation. A subject's baseline measurements prior to sphincter augmentation were compared to post-sphincter augmentation measurements. Subjects served as their own control. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject must be at least 18 years of age and at least the minimum Age of Majority according to applicable State or Country Law and must be less than 75 years of age, with a life expectancy > 3 years
- Subject is a suitable surgical candidate, i.e. is able to undergo general anesthesia and laparoscopic surgery
- Documented typical symptoms of gastroesophageal reflux disease (GERD) for longer than 6 months (regurgitation or heartburn which is defined as a burning epigastic or substernal pain which responds to acid neutralization or suppression)
- Patient requires daily proton pump inhibitor or other anti-reflux drug therapy
- Total Distal Ambulatory Esophageal pH must meet the following criteria: pH< 4 for ≥ 4.5% of the time Note: Subjects shall have discontinued any GERD medications for at least 7 days prior to testing.
Key exclusion criteria (21 listed)
- The procedure is an emergency procedure
- Currently being treated with another investigational drug or investigational device
- History of gastroesophageal surgery, anti-reflux procedures, or gastroesophageal/gastric cancer
- Any previous endoscopic anti-reflux intervention for GERD
- Suspected or confirmed esophageal or gastric cancer
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 |
|---|---|---|
| Magnetic Sphincter AugmentationAlso: LINX Reflux Management System, Magnetic Esophageal SphincterThe area of the lower esophageal sphincter (LES) is accessed using a standard laparoscopic approach. The tubular esophagus, in the area of the LES, is sized and the appropriately sized sphincter augmentation device is placed circumferentially around the esophagus in the area of the LES. After confirming proper placement, the ends of the device are secured. At this point, the implant procedure is complete, laparoscopic instruments are withdrawn and access points are closed. | Device | Magnetic Sphincter Augmentation |
Primary outcome
Rate of Occurrence for Device and Procedure Related Serious Adverse Events (SAEs).
Time frame: through 24 months
SAE was defined as any untoward medical occurrence, whether related to the study device or procedure or not, that meets one or more of the following criteria: * Results in death * Is life-threatening * Requires subject hospitalization > 24 hours * Requires prolongation of an existing hospitalization * Results in persistent or significant disability/incapacity * Results in fetal distress, fetal death, or a congenital anomaly or birth defect * Requires intervention to prevent permanent impairment or damage. Outcome measure reports number of subjects with reported events.
Normalization of Esophageal Acid Exposure Time or Reduced Total Acid Exposure Time of at Least 50% Compared to the Subject's Baseline Measurement by Esophageal pH Testing.
Time frame: 12 Months
The analysis cohort for the primary efficacy analysis was the treated population which includes all implanted subjects and was determined through esophageal pH testing.
2 secondary outcomes
At Least a 50% Reduction in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Total Score Compared to Baseline
Time frame: 12 months
Average Daily Proton-pump Inhibitor (PPI) Dosage Reduced by at Least 50% Compared to Baseline
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26044316Ganz RA, Edmundowicz SA, Taiganides PA, Lipham JC, Smith CD, DeVault KR, Horgan S, Jacobsen G, Luketich JD, Smith CC, Schlack-Haerer SC, Kothari SN, Dunst CM, Watson TJ, Peters J, Oelschlager BK, Perry KA, Melvin S, Bemelman WA, Smout AJ, Dunn D. Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. Clin Gastroenterol Hepatol. 2016 May;14(5):671-7. doi: 10.1016/j.cgh.2015.05.028. Epub 2015 Jun 2.
- Derived from this study: PubMed 23425164Ganz RA, Peters JH, Horgan S, Bemelman WA, Dunst CM, Edmundowicz SA, Lipham JC, Luketich JD, Melvin WS, Oelschlager BK, Schlack-Haerer SC, Smith CD, Smith CC, Dunn D, Taiganides PA. Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med. 2013 Feb 21;368(8):719-27. doi: 10.1056/NEJMoa1205544.
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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.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Sphincter Augmentation in people with Gastroesophageal Reflux, run by Torax Medical Incorporated at 14 sites in 2 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 10 inclusion and 21 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 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Netherlands. 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 13 Nov 2013). 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?
Rate of Occurrence for Device and Procedure Related Serious Adverse Events (SAEs). (time frame: through 24 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 NCT00776997, 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 4 May 2018.