A Prospective Evaluation of the Torax Medical Inc. Magnetic Esophageal Sphincter

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Torax Medical Incorporated
ClinicalTrials.gov Identifier:
NCT01058564
First received: January 26, 2010
Last updated: November 22, 2013
Last verified: November 2013

January 26, 2010
November 22, 2013
May 2008
October 2011   (final data collection date for primary outcome measure)
Prospective performance evaluation of the magnetic esophageal sphincter. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01058564 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Prospective Evaluation of the Torax Medical Inc. Magnetic Esophageal Sphincter
A Prospective Evaluation of the Torax Medical Inc. Magnetic Esophageal Sphincter

Evaluate a novel method of augmenting a weak Lower Esophageal Sphincter (LES).

This study is being conducted to evaluate a novel method of augmenting a weak Lower Esophageal Sphincter (LES) with a magnetic esophageal sphincter device.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastroesophageal Reflux Disease
Device: Torax Medical, Inc. LINX Reflux Management System
Implantable device, magnetic esophageal sphincter
Experimental: Implant device
Intervention: Device: Torax Medical, Inc. LINX Reflux Management System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
  • 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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01058564
1709
No
Torax Medical Incorporated
Torax Medical Incorporated
Not Provided
Principal Investigator: Willem Bemelman, Prof Academisch Medisch Centrum (AMC)
Torax Medical Incorporated
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP