Trials / Completed
CompletedNCT01058070
An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Torax Medical Incorporated · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Torax Medical, Inc. LINX Reflux Management System | Implantable device, Magnetic Esophageal Sphincter |
Timeline
- Start date
- 2007-02-01
- Primary completion
- 2009-07-01
- Completion
- 2013-08-01
- First posted
- 2010-01-28
- Last updated
- 2021-02-01
- Results posted
- 2014-06-02
Locations
5 sites across 3 countries: United States, Italy, Netherlands
Source: ClinicalTrials.gov record NCT01058070. Inclusion in this directory is not an endorsement.