An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter

Gastroesophageal Reflux Disease Clinical Trial

Official title:

An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058070
• Other study ID #: 1306-US, 1030-IT, 1709-NL
• Status: Completed
• Phase: N/A
• Start date: February 2007
• Est. completion date: August 2013

Study information

• Verified date: January 2021
• Source: Torax Medical Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT01057992
• NCT01058564

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2013
• Est. primary completion date: July 2009
• 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/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.

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

Sponsors (1)

Lead Sponsor	Collaborator
Torax Medical Incorporated

Countries where clinical trial is conducted

United States,  Italy,  Netherlands, 

References & Publications (4)

Bonavina L, DeMeester T, Fockens P, Dunn D, Saino G, Bona D, Lipham J, Bemelman W, Ganz RA. Laparoscopic sphincter augmentation device eliminates reflux symptoms and normalizes esophageal acid exposure: one- and 2-year results of a feasibility trial. Ann Surg. 2010 Nov;252(5):857-62. doi: 10.1097/SLA.0b013e3181fd879b. — View Citation

Bonavina L, Saino GI, Bona D, Lipham J, Ganz RA, Dunn D, DeMeester T. Magnetic augmentation of the lower esophageal sphincter: results of a feasibility clinical trial. J Gastrointest Surg. 2008 Dec;12(12):2133-40. doi: 10.1007/s11605-008-0698-1. Epub 2008 Oct 10. — View Citation

Lipham JC, DeMeester TR, Ganz RA, Bonavina L, Saino G, Dunn DH, Fockens P, Bemelman W. The LINX® reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc. 2012 Oct;26(10):2944-9. Epub 2012 Apr 27. — View Citation

Saino G, Bonavina L, Lipham JC, Dunn D, Ganz RA. Magnetic Sphincter Augmentation for Gastroesophageal Reflux at 5 Years: Final Results of a Pilot Study Show Long-Term Acid Reduction and Symptom Improvement. J Laparoendosc Adv Surg Tech A. 2015 Oct;25(10):787-92. doi: 10.1089/lap.2015.0394. Epub 2015 Oct 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Evaluate the Incidence of All Adverse Events at Various Time Points.		5 years
Primary	To Monitor the Improvement of GERD Symptoms.	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