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:
NCT01057992
First received: January 26, 2010
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

A medical device to augment weak lower esophageal sphincter function.


Condition Intervention Phase
Gastroesophageal Reflux Disease
Device: Magnetic Esophageal Sphincter
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: Three years ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: March 2007
Study Completion Date: January 2013
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Implantable Device Device: Magnetic Esophageal Sphincter
Implantable device
Other Name: LINX Reflux Management System

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, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057992

Locations
Italy
Policlinico San Donato
Milan, Italy
Sponsors and Collaborators
Torax Medical Incorporated
  More Information

No publications provided

Responsible Party: Torax Medical Incorporated
ClinicalTrials.gov Identifier: NCT01057992     History of Changes
Other Study ID Numbers: 1030
Study First Received: January 26, 2010
Last Updated: November 22, 2013
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on April 16, 2014