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: NCT01057992
• Other study ID #: 1030
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 26, 2010
• Last updated: November 22, 2013
• Start date: March 2007
• Est. completion date: January 2013

Study information

• Verified date: November 2013
• Source: Torax Medical Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

A medical device to augment weak lower esophageal sphincter function.

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: 31
• Est. completion date: January 2013
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• 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, 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Device:
• Magnetic Esophageal Sphincter
Implantable device

Locations

Country	Name	City	State
Italy	Policlinico San Donato	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Torax Medical Incorporated

Country where clinical trial is conducted

Italy, 

Outcome

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