An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter

January 28, 2021 updated by: Torax Medical Incorporated
Magnetic Esophageal Sphincter implant is intended to reinforce Esophageal Sphincter function in the treatment of Gastroesophageal Reflux Disease (GERD)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20097
        • Policlinico San Donato
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum (AMC)
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California, Keck School of Medicine
      • Orange, California, United States, 92869
        • Chapman Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implantable Device
Subjects who meet eligibility criteria are implanted with the Magnetic Esophageal Sphincter device (MES)
Device: Torax Medical, Inc. LINX Reflux Management System
Implantable device, Magnetic Esophageal Sphincter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Evaluate the Incidence of All Adverse Events at Various Time Points.
Time Frame: 5 years
5 years
To Monitor the Improvement of GERD Symptoms.
Time Frame: 5 years
Percentage of participants with a 50% or more reduction in total GERD-HRQL score is indicative of a substantial improvement in GERD symptoms
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Torax Medical Incorporated

Investigators

  • Principal Investigator: Robert Ganz, MD, Minnesota Gastroenterolgy, PA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

January 26, 2010

First Submitted That Met QC Criteria

January 27, 2010

First Posted (Estimate)

January 28, 2010

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1306-US, 1030-IT, 1709-NL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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