Gastroesophageal Reflux DiseaseNCT01058070

An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter

A study testing Torax Medical, Inc. LINX Reflux Management System in people with Gastroesophageal Reflux Disease, run by Torax Medical Incorporated at 5 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Magnetic Esophageal Sphincter implant is intended to reinforce Esophageal Sphincter function in the treatment of Gastroesophageal Reflux Disease (GERD) Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Gastroesophageal Reflux Disease
What is being tested?: Torax Medical, Inc. LINX Reflux Management System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 5 sitesin 3 countries
Study dates: Feb 2007to Aug 2013
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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years, < 85 years, life expectancy > 3yrs.
Documented history of GERD symptoms such as heartburn and/or regurgitation.
On daily PPI treatment for at least 3-months.
Responsive to PPI treatment.
GERD symptoms, in absence of PPI therapy (minimum 10 days).
Ambulatory Esophageal pH < 4 for ≥ 5% time or pH < 4 for ≥ 3% time in supine position.

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Patient is a surgical candidate.
Patient is willing and able to cooperate with follow-up examinations.
Patient has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes (HIPAA).

Who cannot join

The procedure is an emergency procedure.
Patient is currently being treated with another investigational drug or investigational device.
Patient has had prior gastric or esophageal surgery.
Patient has had any previous endoscopic intervention for GERD
Patient has suspected or confirmed esophageal or gastric cancer.
Patient has any size paraesophageal hiatal hernia or sliding hiatal hernia ≥3cm. (Investigator to identify and record type of hiatal hernia at the time of assessment (i.e. para-esophageal, sliding)).

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Patient's esophageal motility is less than 35 mmHg peristaltic amplitude on wet swallows or > 30% failed (non-propulsive) peristaltic sequences.
Patient has esophagitis - Grade B, C, D (LA Classification).
Patient has Barretts Esophagus.
Patient has BMI > 35.
Patient has symptoms of dysphagia or indications of dysphagia from barium esophagram.
Patient has Scleroderma and/or Achalasia.
Patient has an esophageal stricture or gross esophageal anatomic abnormalities (obstructive lesions, etc.).
Patient has an electrical implant or metallic, abdominal implant(s).
Patient cannot understand trial requirements or is unable to comply with follow-up schedule.
Patient is pregnant or nursing, or plans to become pregnant.
Patient has a psychiatric disorder.

Trial locations and contacts

5 sites in 3 countries.

Country

City, postcode or hospital

5 sites in 3 countries

United States3 sites

University of Southern California, Keck School of Medicine
Los Angeles, California, 90033
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Chapman Medical Center
Orange, California, 92869

Other trials in United States

Italy1 site

Policlinico San Donato
Milan, 20097

Other trials in Italy

Netherlands1 site

Academisch Medisch Centrum (AMC)
Amsterdam, 1105 AZ

Other trials in Netherlands

About this study

Magnetic Esophageal Sphincter implant is intended to reinforce Esophageal Sphincter function in the treatment of Gastroesophageal Reflux Disease (GERD)

Read the detailed description

The purpose of this feasibility study is to collect preliminary performance and safety information and develop procedural optimization for the Torax Medical Inc. Magnetic Esophageal Sphincter device (MES) in reinforcement of Esophageal Sphincter function to treat Gastroesophageal Reflux Disease (GERD). The information from this study will be used to support the design and conduct of an expanded clinical trial.

Conditions: Gastroesophageal Reflux Disease
Being tested: Torax Medical, Inc. LINX Reflux Management System
Keywords: GERD
Medical subject headings: Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Torax Medical, Inc. LINX Reflux Management SystemDevice
Implantable device, Magnetic Esophageal Sphincter

Study groups in NCT01058070
Study group	Role	What they receive
Implantable Device	Experimental	Subjects who meet eligibility criteria are implanted with the Magnetic Esophageal Sphincter device (MES) Receives: Device: Torax Medical, Inc. LINX Reflux Management System

What is being measured

The primary outcome is the main question the study is designed to answer.

To Evaluate the Incidence of All Adverse Events at Various Time Points.
Measured: 5 years
To Monitor the Improvement of GERD Symptoms.
Percentage of participants with a 50% or more reduction in total GERD-HRQL score is indicative of a substantial improvement in GERD symptoms
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Aug 2013

First posted28 Jan 2010 (estimated)
Study startFeb 2007
Primary completionJul 2009
Study completionAug 2013

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 (4)Papers the sponsor has linked to this study.
Other trials for Gastroesophageal Reflux DiseaseStudies 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: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01058070
Sponsor's protocol ID: 1306-US, 1030-IT, 1709-NL
Status last verified: Jan 2021
First submitted: 26 Jan 2010
Last updated: 1 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bonavina L, Saino GI, Bona D, Lipham J, Ganz RA, Dunn D, DeMeester T. Magnetic augmentation of the lower esophageal sphincter: results of a feasibility clinical trial. J Gastrointest Surg. 2008 Dec;12(12):2133-40. doi: 10.1007/s11605-008-0698-1. Epub 2008 Oct 10.
PubMed 18846406
Bonavina L, DeMeester T, Fockens P, Dunn D, Saino G, Bona D, Lipham J, Bemelman W, Ganz RA. Laparoscopic sphincter augmentation device eliminates reflux symptoms and normalizes esophageal acid exposure: one- and 2-year results of a feasibility trial. Ann Surg. 2010 Nov;252(5):857-62. doi: 10.1097/SLA.0b013e3181fd879b.
PubMed 21037442
Lipham JC, DeMeester TR, Ganz RA, Bonavina L, Saino G, Dunn DH, Fockens P, Bemelman W. The LINX(R) reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc. 2012 Oct;26(10):2944-9. doi: 10.1007/s00464-012-2289-1. Epub 2012 Apr 27.
PubMed 22538694
Saino G, Bonavina L, Lipham JC, Dunn D, Ganz RA. Magnetic Sphincter Augmentation for Gastroesophageal Reflux at 5 Years: Final Results of a Pilot Study Show Long-Term Acid Reduction and Symptom Improvement. J Laparoendosc Adv Surg Tech A. 2015 Oct;25(10):787-92. doi: 10.1089/lap.2015.0394. Epub 2015 Oct 5.
PubMed 26437027

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gastroesophageal Reflux Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter
ClinicalTrials.gov ID: NCT01058070
Acronym / sponsor ID: 1306-US, 1030-IT, 1709-NL
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Torax Medical IncorporatedIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Jul 2009 (actual)
Study completion: Aug 2013 (actual)
First posted: 28 Jan 2010 (estimated)
Results: Posted 2 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Magnetic Esophageal Sphincter implant is intended to reinforce Esophageal Sphincter function in the treatment of Gastroesophageal Reflux Disease (GERD)

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Implantable Device	Experimental	Device: Torax Medical, Inc. LINX Reflux Management SystemSubjects who meet eligibility criteria are implanted with the Magnetic Esophageal Sphincter device (MES)

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Age ≥ 18 years, < 85 years, life expectancy > 3yrs.
Documented history of GERD symptoms such as heartburn and/or regurgitation.
On daily PPI treatment for at least 3-months.
Responsive to PPI treatment.
GERD symptoms, in absence of PPI therapy (minimum 10 days).

Key exclusion criteria (17 listed)

The procedure is an emergency procedure.
Patient is currently being treated with another investigational drug or investigational device.
Patient has had prior gastric or esophageal surgery.
Patient has had any previous endoscopic intervention for GERD
Patient has 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
Torax Medical, Inc. LINX Reflux Management SystemImplantable device, Magnetic Esophageal Sphincter	Device	Implantable Device

Primary outcome

To Evaluate the Incidence of All Adverse Events at Various Time Points.
Time frame: 5 years
To Monitor the Improvement of GERD Symptoms.
Time frame: 5 years
Percentage of participants with a 50% or more reduction in total GERD-HRQL score is indicative of a substantial improvement in GERD symptoms

Results and safety

Results posted to the registry on 2 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Implantable Device	44	33

Primary outcome: To Evaluate the Incidence of All Adverse Events at Various Time Points.

Time frame: 5 years. Number. Unit: participants

Measure	LINX Study Subjects n = 44
Value	29

Primary outcome: To Monitor the Improvement of GERD Symptoms.

Time frame: 5 years. Number. Unit: percentage of participants

Measure	Implantable Device n = 33
Value	93.9

Adverse events

Time frame: Pre-discharge, 2-Weeks, 6-Weeks, 3-Months, 6-Months, 12-Months, 18-Months, 24-Months, 30-Months, 36-Months, 42-Months, 48-Months, 54-Months, and 60-Months Follow-up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Implantable Device	3 of 44 (6.8%)	25 of 44 (56.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18846406Bonavina L, Saino GI, Bona D, Lipham J, Ganz RA, Dunn D, DeMeester T. Magnetic augmentation of the lower esophageal sphincter: results of a feasibility clinical trial. J Gastrointest Surg. 2008 Dec;12(12):2133-40. doi: 10.1007/s11605-008-0698-1. Epub 2008 Oct 10.
Background: PubMed 21037442Bonavina L, DeMeester T, Fockens P, Dunn D, Saino G, Bona D, Lipham J, Bemelman W, Ganz RA. Laparoscopic sphincter augmentation device eliminates reflux symptoms and normalizes esophageal acid exposure: one- and 2-year results of a feasibility trial. Ann Surg. 2010 Nov;252(5):857-62. doi: 10.1097/SLA.0b013e3181fd879b.
Background: PubMed 22538694Lipham JC, DeMeester TR, Ganz RA, Bonavina L, Saino G, Dunn DH, Fockens P, Bemelman W. The LINX(R) reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc. 2012 Oct;26(10):2944-9. doi: 10.1007/s00464-012-2289-1. Epub 2012 Apr 27.
Background: PubMed 26437027Saino G, Bonavina L, Lipham JC, Dunn D, Ganz RA. Magnetic Sphincter Augmentation for Gastroesophageal Reflux at 5 Years: Final Results of a Pilot Study Show Long-Term Acid Reduction and Symptom Improvement. J Laparoendosc Adv Surg Tech A. 2015 Oct;25(10):787-92. doi: 10.1089/lap.2015.0394. Epub 2015 Oct 5.

Related trials for Gastroesophageal Reflux Disease

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
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Recruiting
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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.

Robert Ganz, MD principal investigator

Minnesota Gastroenterolgy, PA

5 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Torax Medical, Inc. LINX Reflux Management System in people with Gastroesophageal Reflux Disease, run by Torax Medical Incorporated at 5 sites in 3 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 9 inclusion and 17 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 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Italy, 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 2 Jun 2014). 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?

To Evaluate the Incidence of All Adverse Events at Various Time Points. (time frame: 5 years). 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 NCT01058070, which also lists 4 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 1 Feb 2021.