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An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter

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ClinicalTrials.gov Identifier: NCT01058070
Recruitment Status : Completed
First Posted : January 28, 2010
Results First Posted : June 2, 2014
Last Update Posted : June 2, 2014
Sponsor:
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 Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
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 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



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01058070


Locations
United States, California
Chapman Medical Center
Orange, California, United States
United States, Minnesota
Abbott Northwestern
Minneapolis, Minnesota, United States
Sponsors and Collaborators
Torax Medical Incorporated
Investigators
Principal Investigator: Robert Ganz, MD Minnesota Gastroenterolgy, PA

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Torax Medical Incorporated
ClinicalTrials.gov Identifier: NCT01058070     History of Changes
Other Study ID Numbers: 1306
First Posted: January 28, 2010    Key Record Dates
Results First Posted: June 2, 2014
Last Update Posted: June 2, 2014
Last Verified: May 2014

Keywords provided by Torax Medical Incorporated:
GERD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases