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
  Purpose

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


Condition Intervention Phase
Gastroesophageal Reflux Disease
Device: Torax Medical, Inc. LINX Reflux Management System
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of the Torax Medical Inc. Magnetic Esophageal Sphincter

Resource links provided by NLM:


Further study details as provided by Torax Medical Incorporated:

Primary Outcome Measures:
  • Prospective performance evaluation of the magnetic esophageal sphincter. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: May 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Implant device Device: Torax Medical, Inc. LINX Reflux Management System
Implantable device, magnetic esophageal sphincter

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058564

Locations
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands
Sponsors and Collaborators
Torax Medical Incorporated
Investigators
Principal Investigator: Willem Bemelman, Prof Academisch Medisch Centrum (AMC)
  More Information

No publications provided

Responsible Party: Torax Medical Incorporated
ClinicalTrials.gov Identifier: NCT01058564     History of Changes
Other Study ID Numbers: 1709
Study First Received: January 26, 2010
Last Updated: November 22, 2013
Health Authority: Netherlands: Dutch Health Care Inspectorate

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

ClinicalTrials.gov processed this record on September 16, 2014