A Prospective Evaluation of the Torax Medical Inc. Magnetic Esophageal Sphincter
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ClinicalTrials.gov Identifier: NCT01057992 |
Recruitment Status :
Completed
First Posted : January 28, 2010
Last Update Posted : November 25, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastroesophageal Reflux Disease | Device: Magnetic Esophageal Sphincter | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 31 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective Evaluation of the Torax Medical Inc. Magnetic Esophageal Sphincter |
Study Start Date : | March 2007 |
Actual Primary Completion Date : | October 2009 |
Actual Study Completion Date : | January 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Implantable Device |
Device: Magnetic Esophageal Sphincter
Implantable device
Other Name: LINX Reflux Management System |
- Prospective performance evaluation of the magnetic esophageal sphincter [ Time Frame: Three years ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18 years, < 85 years, life expectancy > 3yrs.
- Documented history of GERD symptoms such as heartburn and regurgitation.
- On daily PPI treatment for at least 3-months.
- Partially 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.
- Patient is a surgical candidate.
- Patient is able to understand and provide written informed consent, or have a legally acceptable representative understand and give written informed consent.
- Patient is willing and able to cooperate with follow-up examinations.
Exclusion Criteria:
- The procedure is an emergency procedure.
- Patient is currently being treated with another investigational drug or investigational mechanical support device.
- Prior Gastric or Esophageal Surgery.
- Any Endoscopic Intervention
- Suspected or confirmed Esophageal or Gastric Cancer.
- Hiatal Hernia ≥ 3cm by endoscopy
- Esophageal motility less than 30mmHg peristaltic amplitude on wet swallows and/or > 30% synchronous/repetitive waves.
- Esophagitis - Grade IV
- Barretts Esophagus.
- Gross obesity (BMI > 35).
- Symptoms of dysphagia or indications of dysphagia from esophagram.
- Patient has Scleroderma and/or Achalasia
- Gross esophageal anatomic abnormalities (obstructive lesions, significant strictures, etc)
- Patient cannot understand trial requirements or is unable to comply with follow-up schedule.
- Patient is pregnant or nursing, or plans to become pregnant.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01057992
Italy | |
Policlinico San Donato | |
Milan, Italy |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Torax Medical Incorporated |
ClinicalTrials.gov Identifier: | NCT01057992 History of Changes |
Other Study ID Numbers: |
1030 |
First Posted: | January 28, 2010 Key Record Dates |
Last Update Posted: | November 25, 2013 |
Last Verified: | November 2013 |
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |