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An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01058070
Recruitment Status : Completed
First Posted : January 28, 2010
Results First Posted : June 2, 2014
Last Update Posted : February 1, 2021
Information provided by (Responsible Party):
Torax Medical Incorporated

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

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Device: Torax Medical, Inc. LINX Reflux Management System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter
Study Start Date : February 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: Implantable Device
Subjects who meet eligibility criteria are implanted with the Magnetic Esophageal Sphincter device (MES)
Device: Torax Medical, Inc. LINX Reflux Management System
Implantable device, Magnetic Esophageal Sphincter

Primary Outcome Measures :
  1. To Evaluate the Incidence of All Adverse Events at Various Time Points. [ Time Frame: 5 years ]
  2. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.
  • 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).

Exclusion Criteria:

  • 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)).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01058070

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United States, California
University of Southern California, Keck School of Medicine
Los Angeles, California, United States, 90033
Chapman Medical Center
Orange, California, United States, 92869
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Policlinico San Donato
Milano, Italy, 20097
Academisch Medisch Centrum (AMC)
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Torax Medical Incorporated
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Principal Investigator: Robert Ganz, MD Minnesota Gastroenterolgy, PA
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Responsible Party: Torax Medical Incorporated Identifier: NCT01058070    
Obsolete Identifiers: NCT01057992, NCT01058564
Other Study ID Numbers: 1306-US, 1030-IT, 1709-NL
First Posted: January 28, 2010    Key Record Dates
Results First Posted: June 2, 2014
Last Update Posted: February 1, 2021
Last Verified: January 2021
Keywords provided by Torax Medical Incorporated:
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases