N/A
Completed N=100
LINX Reflux Management System Clinical Study Protocol
Source: ClinicalTrials.gov NCT00776997 ↗Enrolled (actual)
100
Serious AEs
6.0%
Results posted
Nov 2013
Primary outcomePrimary: Rate of Occurrence for Device and Procedure Related Serious Adverse Events (SAEs). — 6 participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Occurrence for Device and Procedure Related Serious Adverse Events (SAEs). |
6 | — |
| PRIMARY Normalization of Esophageal Acid Exposure Time or Reduced Total Acid Exposure Time of at Least 50% Compared to the Subject's Baseline Measurement by Esophageal pH Testing. |
64 | — |
| SECONDARY At Least a 50% Reduction in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Total Score Compared to Baseline |
92 | — |
| SECONDARY Average Daily Proton-pump Inhibitor (PPI) Dosage Reduced by at Least 50% Compared to Baseline |
93 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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 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
Data sourced from ClinicalTrials.gov (NCT00776997). 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. Informational only — not medical advice.