Status:
COMPLETED
LINX Reflux Management System Clinical Study Protocol
Lead Sponsor:
Torax Medical Incorporated
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate the safety and effectiveness of the LINX Reflux Management System in the treatment of Gastroesophageal Reflux Disease (GERD).
Detailed Description
At present, the primary alternative for GERD patients with an incomplete symptomatic response to proton-pump inhibitors (PPIs) is laparoscopic Nissen fundoplication. This surgical procedure continues ...
Eligibility Criteria
Inclusion
- Subject must be at least 18 years of age and at least the minimum Age of Majority according to applicable State or Country Law and must be less than 75 years of age, with a life expectancy \> 3 years
- Subject is a suitable surgical candidate, i.e. is able to undergo general anesthesia and laparoscopic surgery
- Documented typical symptoms of gastroesophageal reflux disease (GERD) for longer than 6 months (regurgitation or heartburn which is defined as a burning epigastic or substernal pain which responds to acid neutralization or suppression)
- Patient requires daily proton pump inhibitor or other anti-reflux drug therapy
- Total Distal Ambulatory Esophageal pH must meet the following criteria: pH\< 4 for ≥ 4.5% of the time Note: Subjects shall have discontinued any GERD medications for at least 7 days prior to testing.
- Subjects with symptomatic improvement on proton-pump inhibitor (PPI) therapy demonstrated by a GERD-Health-Related Quality of Life (GERD-HRQL) score of ≤ 10 on proton-pump inhibitors and ≥ 15 off PPIs, or subjects with a ≥ 6 point improvement when comparing their on PPI and off PPI GERD-HRQL score
- GERD symptoms, in absence of PPI therapy (minimum 7 days)
- If the subject is of child bearing potential must have a negative pregnancy test within one week prior to implant and must agree to use effective means of birth control during the course of the study
- Subject is willing and able to cooperate with follow-up examinations
- Subject has been informed of the study procedures and the treatment and has signed an informed consent form
Exclusion
- The procedure is an emergency procedure
- Currently being treated with another investigational drug or investigational device
- History of gastroesophageal surgery, anti-reflux procedures, or gastroesophageal/gastric cancer
- Any previous endoscopic anti-reflux intervention for GERD
- Suspected or confirmed esophageal or gastric cancer
- Any size hiatal hernia \>3cm as determined by endoscopy
- Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg peristaltic amplitude on wet swallows or \<70% (propulsive) peristaltic sequences
- Esophagitis - Grade C or D (LA Classification)
- Body Mass Index (BMI)\>35
- Symptoms of dysphagia more than once per week within the last 3 months.
- Diagnosed with Scleroderma
- Diagnosed with an esophageal motility disorder such as but not limited to Achalasia, Nutcracker Esophagus, or Diffuse Esophageal Spasm or Hypertensive LES
- Subject has a history of or known esophageal stricture or gross esophageal anatomic abnormalities (Schatzki's ring, obstructive lesions, etc.)
- Subject has esophageal or gastric varices
- Subject has history of or known Barrett's esophagus
- Cannot understand trial requirements or is unable to comply with follow-up schedule
- Pregnant or nursing, or plans to become pregnant during the course of the study
- Medical illness (i.e. congestive heart failure) that may cause the subject to be non-compliant with or able to meet the protocol requirements or is associated with limited life expectancy (i.e. less than 3 years)
- Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that exhibit depression that are on appropriate medication(s) are allowable.
- Suspected or known allergies to titanium, stainless steel, nickel or ferrous materials
- Subject has an electrical implant or metallic, abdominal implants
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00776997
Start Date
November 1 2008
End Date
September 1 2011
Last Update
May 4 2018
Active Locations (14)
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1
USC Keck School of Medicine
Los Angeles, California, United States, 90033
2
University of California - San Diego
San Diego, California, United States, 92103
3
Mayo Clinic
Jacksonville, Florida, United States, 32224
4
Phoebe Putney Memorial Hospital
Albany, Georgia, United States, 31701