An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2013-08-31

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)

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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.

Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Implantable Device

Subjects who meet eligibility criteria are implanted with the Magnetic Esophageal Sphincter device (MES)

Group Type EXPERIMENTAL

Torax Medical, Inc. LINX Reflux Management System

Intervention Type DEVICE

Implantable device, Magnetic Esophageal Sphincter

Interventions

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Torax Medical, Inc. LINX Reflux Management System

Implantable device, Magnetic Esophageal Sphincter

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No