N/A
N=44
An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter
Gastroesophageal Reflux Disease
Bottom Line
View on ClinicalTrials.gov: NCT01058070 ↗Enrolled (actual)
44
Serious AEs
6.8%
Results posted
Jun 2014
Primary outcome: Primary: To Evaluate the Incidence of All Adverse Events at Various Time Points. — 29 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Torax Medical, Inc. LINX Reflux Management System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Torax Medical Incorporated
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Evaluate the Incidence of All Adverse Events at Various Time Points. |
29 | — |
| PRIMARY To Monitor the Improvement of GERD Symptoms. |
93.9 | — |
Summary
Magnetic Esophageal Sphincter implant is intended to reinforce Esophageal Sphincter function in the treatment of Gastroesophageal Reflux Disease (GERD)
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years, 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 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.
Data sourced from ClinicalTrials.gov (NCT01058070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.