An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Torax Medical Incorporated
ClinicalTrials.gov Identifier:
NCT01058070
First received: January 26, 2010
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

Magnetic Esophageal Sphincter implant is intended to reinforce Esophageal Sphincter function in the treatment of Gastroesophageal Reflux Disease (GERD)


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: An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter

Resource links provided by NLM:


Further study details as provided by Torax Medical Incorporated:

Primary Outcome Measures:
  • To Evaluate the Incidence of All Adverse Events at Various Time Points. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • To Monitor the Improvement of GERD Symptoms. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Percentage of participants with a 50% or more reduction in total GERD-HRQL score is indicative of a substantial improvement in GERD symptoms


Enrollment: 44
Study Start Date: February 2007
Study Completion Date: August 2013
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Implantable Device Device: Torax Medical, Inc. LINX Reflux Management System
Implantable device, Magnetic Esophageal Sphincter

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.

  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/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.
  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: 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
  More Information

No publications provided

Responsible Party: Torax Medical Incorporated
ClinicalTrials.gov Identifier: NCT01058070     History of Changes
Other Study ID Numbers: 1306
Study First Received: January 26, 2010
Results First Received: March 3, 2014
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

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 July 26, 2014