Gastroesophageal Reflux Disease
Conditions
Keywords
GERD
Brief 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.
Interventions
DEVICETorax Medical, Inc. LINX Reflux Management System
Implantable device, Magnetic Esophageal Sphincter
Sponsors
Torax Medical Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years, \< 85 years, life expectancy \> 3yrs. * Documented history of GERD symptoms such as heartburn and/or regurgitation. * On daily PPI treatment for at least 3-months. * 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 position. * Patient is a surgical candidate. * Patient is willing and able to cooperate with follow-up examinations. * Patient has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes (HIPAA).
Exclusion criteria
* The procedure is an emergency procedure. * Patient is currently being treated with another investigational drug or investigational device. * Patient has had prior gastric or esophageal surgery. * Patient has had any previous endoscopic intervention for GERD * Patient has suspected or confirmed esophageal or gastric cancer. * Patient has any size paraesophageal hiatal hernia or sliding hiatal hernia ≥3cm. (Investigator to identify and record type of hiatal hernia at the time of assessment (i.e. para-esophageal, sliding)). * Patient's esophageal motility is less than 35 mmHg peristaltic amplitude on wet swallows or \> 30% failed (non-propulsive) peristaltic sequences. * Patient has esophagitis - Grade B, C, D (LA Classification). * Patient has Barretts Esophagus. * Patient has BMI \> 35. * Patient has symptoms of dysphagia or indications of dysphagia from barium esophagram. * Patient has Scleroderma and/or Achalasia. * Patient has an esophageal stricture or gross esophageal anatomic abnormalities (obstructive lesions, etc.). * Patient has an electrical implant or metallic, abdominal implant(s). * Patient cannot understand trial requirements or is unable to comply with follow-up schedule. * Patient is pregnant or nursing, or plans to become pregnant. * Patient has a psychiatric disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate the Incidence of All Adverse Events at Various Time Points. | 5 years | — |
| To Monitor the Improvement of GERD Symptoms. | 5 years | Percentage of participants with a 50% or more reduction in total GERD-HRQL score is indicative of a substantial improvement in GERD symptoms |
Countries
Italy, Netherlands, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Implantable Device Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Implantable Device |
|---|---|
| Age, Continuous | 42.8 years |
| Body Mass Index (BMI) | 25.7 kg/m^2 |
| Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) | 26.5 scores on a scale |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 26 Participants |
| % time esophageal pH<4 | 11.9 percentage |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 25 / 44 |
| serious Total, serious adverse events | 3 / 44 |
Outcome results
Primary
To Evaluate the Incidence of All Adverse Events at Various Time Points.
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LINX Study Subjects | To Evaluate the Incidence of All Adverse Events at Various Time Points. | 29 participants |
Primary
To Monitor the Improvement of GERD Symptoms.
Percentage of participants with a 50% or more reduction in total GERD-HRQL score is indicative of a substantial improvement in GERD symptoms
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LINX Study Subjects | To Monitor the Improvement of GERD Symptoms. | 93.9 percentage of participants |