A Prospective Evaluation of the Torax Medical Inc. Magnetic Esophageal Sphincter
This study has been completed.
Sponsor:
Torax Medical Incorporated
Information provided by (Responsible Party):
Torax Medical Incorporated
ClinicalTrials.gov Identifier:
NCT01058564
First received: January 26, 2010
Last updated: May 30, 2012
Last verified: May 2012
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Purpose
Evaluate a novel method of augmenting a weak Lower Esophageal Sphincter (LES).
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux Disease |
Device: Torax Medical, Inc. LINX Reflux Management System |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Evaluation of the Torax Medical Inc. Magnetic Esophageal Sphincter |
Resource links provided by NLM:
Further study details as provided by Torax Medical Incorporated:
Primary Outcome Measures:
- Prospective performance evaluation of the magnetic esophageal sphincter. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 4 |
| Study Start Date: | May 2008 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Implant device |
Device: Torax Medical, Inc. LINX Reflux Management System
Implantable device, magnetic esophageal sphincter
|
Detailed Description:
This study is being conducted to evaluate a novel method of augmenting a weak Lower Esophageal Sphincter (LES) with a magnetic esophageal sphincter device.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
- 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Torax Medical Incorporated |
| ClinicalTrials.gov Identifier: | NCT01058564 History of Changes |
| Other Study ID Numbers: | 1709 |
| Study First Received: | January 26, 2010 |
| Last Updated: | May 30, 2012 |
| Health Authority: | Netherlands: Dutch Health Care Inspectorate |
Keywords provided by Torax Medical Incorporated:
|
GERD |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013