An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter

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

Detailed Description
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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.

Official Title
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An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Device: Torax Medical, Inc. LINX Reflux Management System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implantable Device<br>Subjects who meet eligibility criteria are implanted with the Magnetic Esophageal Sphincter device (MES) | Device: Torax Medical, Inc. LINX Reflux Management System<br>* Implantable device, Magnetic Esophageal Sphincter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate the Incidence of All Adverse Events at Various Time Points. |  | 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 | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD