Clinical trial NCT01058070: An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter
Official title: An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
Lead sponsor: Torax Medical Incorporated
Sponsor class: INDUSTRY
First posted: 2010-01-28
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To Evaluate the Incidence of All Adverse Events at Various Time Points.
timeFrame: 5 years
measure: To Monitor the Improvement of GERD Symptoms.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California, Keck School of Medicine
state: California
city: Orange
country: United States
facility: Chapman Medical Center
state: California
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Milano
country: Italy
facility: Policlinico San Donato
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum (AMC)
Study officials:
affiliation: Minnesota Gastroenterolgy, PA
name: Robert Ganz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
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.