Magnetic Esophageal Sphincter implant is intended to reinforce Esophageal Sphincter function
in the treatment of Gastroesophageal Reflux Disease (GERD)
Device: Torax Medical, Inc. LINX Reflux Management System
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Locations near you
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Full eligibility criteria for NCT01058070
Ages eligible for Study
18 Years to 85 Years
Genders eligible for Study
Accepts Healthy Volunteers
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).
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.
All locations for NCT01058070
United States (2)
Chapman Medical Center
Orange, California, United States
Minneapolis, Minnesota, United States
Trial results for NCT01058070
Participant Flow: Overall Study
33 / 44
Completed / Started
Serious Adverse Events
3 / 44
Affected / At Risk
Other Adverse Events
25 / 44
Affected / At Risk
View full eligibility
Tris trial is registered with FDA with number: NCT01058070. The sponsor of the trial is Torax Medical Incorporated and it is looking for 44 volunteers for the current phase.
Official trial title: An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter
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