An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter

NCT01058070 | Completed Results

• 1 other identifier: 1306-US, 1030-IT, 1709-NL
• Study Type: interventional
• Target: 44
• Locations: 3 countries
• Sites: 5

Brief Summary

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

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD

Outcome Measures

Primary Outcomes (2)

• To Evaluate the Incidence of All Adverse Events at Various Time Points.

  5 years

• 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

Study Arms (1)

Implantable Device

EXPERIMENTAL

Subjects who meet eligibility criteria are implanted with the Magnetic Esophageal Sphincter device (MES)

Device: Torax Medical, Inc. LINX Reflux Management System

Interventions

Torax Medical, Inc. LINX Reflux Management System DEVICE

Implantable device, Magnetic Esophageal Sphincter

Implantable Device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Torax Medical Incorporated: lead

Study Sites (5)

University of Southern California, Keck School of Medicine

Los Angeles, California, 90033, United States

Location

Chapman Medical Center

Orange, California, 92869, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Policlinico San Donato

Milan, 20097, Italy

Location

Academisch Medisch Centrum (AMC)

Amsterdam, 1105 AZ, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 18846406 BACKGROUND

• 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.

  PMID: 21037442 BACKGROUND

• Lipham JC, DeMeester TR, Ganz RA, Bonavina L, Saino G, Dunn DH, Fockens P, Bemelman W. The LINX(R) reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc. 2012 Oct;26(10):2944-9. doi: 10.1007/s00464-012-2289-1. Epub 2012 Apr 27.

  PMID: 22538694 BACKGROUND

• 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.

  PMID: 26437027 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: VP of Clinical Affairs
• Organization: Torax Medical, Inc.

aderosier@toraxmedical.com

651-361-8900

Study Officials

• Robert Ganz, MD

  Minnesota Gastroenterolgy, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 28, 2010
• Study Start: February 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2013
• Last Updated: February 1, 2021
• Results First Posted: June 2, 2014

Record last verified: 2021-01

Locations

US (3); IT (1); NL (1)