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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058564
• Other study ID #: 1709
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2008
• Est. completion date: October 2011

Study information

• Verified date: September 2019
• Source: Torax Medical Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Device:
• Torax Medical, Inc. LINX Reflux Management System
Implantable device, magnetic esophageal sphincter

Locations

Country	Name	City	State
Netherlands	Academisch Medisch Centrum	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Torax Medical Incorporated

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prospective performance evaluation of the magnetic esophageal sphincter.		3 years