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A Prospective Evaluation of the Torax Medical Inc. 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.
 
ClinicalTrials.gov Identifier: NCT01057992
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Torax Medical Incorporated

Study Description
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Brief Summary:
A medical device to augment weak lower esophageal sphincter function.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Device: Magnetic Esophageal Sphincter Phase 1 Phase 2

Detailed Description:
This study is being conducted to evaluate a novel method of augmenting a weak Lower Esophageal Sphincter (LES) with a magnetic esophageal sphincter device.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of the Torax Medical Inc. Magnetic Esophageal Sphincter
Study Start Date : March 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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Arm Intervention/treatment
Experimental: Implantable Device Device: Magnetic Esophageal Sphincter
Implantable device
Other Name: LINX Reflux Management System


Outcome Measures
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Primary Outcome Measures :
  1. Prospective performance evaluation of the magnetic esophageal sphincter [ Time Frame: Three years ]

Eligibility Criteria
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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 regurgitation.
  • On daily PPI treatment for at least 3-months.
  • Partially 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.
  • Patient is a surgical candidate.
  • Patient is able to understand and provide written informed consent, or have a legally acceptable representative understand and give written informed consent.
  • Patient is willing and able to cooperate with follow-up examinations.

Exclusion Criteria:

  • The procedure is an emergency procedure.
  • Patient is currently being treated with another investigational drug or investigational mechanical support device.
  • Prior Gastric or Esophageal Surgery.
  • Any Endoscopic Intervention
  • Suspected or confirmed Esophageal or Gastric Cancer.
  • Hiatal Hernia ≥ 3cm by endoscopy
  • Esophageal motility less than 30mmHg peristaltic amplitude on wet swallows and/or > 30% synchronous/repetitive waves.
  • Esophagitis - Grade IV
  • Barretts Esophagus.
  • Gross obesity (BMI > 35).
  • Symptoms of dysphagia or indications of dysphagia from esophagram.
  • Patient has Scleroderma and/or Achalasia
  • Gross esophageal anatomic abnormalities (obstructive lesions, significant strictures, etc)
  • Patient cannot understand trial requirements or is unable to comply with follow-up schedule.
  • Patient is pregnant or nursing, or plans to become pregnant.
Contacts and Locations
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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): NCT01057992


Locations
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Italy
Policlinico San Donato
Milan, Italy
Sponsors and Collaborators
Torax Medical Incorporated
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Torax Medical Incorporated
ClinicalTrials.gov Identifier: NCT01057992    
Other Study ID Numbers: 1030
First Posted: January 28, 2010    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases