Ensayos clínicos

Inclusion Criteria:

• Hstory of heartburn-like pain, regurgitation, or both prior to the initiation of proton pump inhibitor (PPIs) therapy.
• History of GERD symptoms of at least six months despite continuous PPIs.
• GERD-HRQL score ≥15 after discontinuing PPI therapy.
• GERD-HRQL score improvement of at least 6 points while on PPIs, with at least 4-point improvement in heartburn subscore.
• A minimum GERD-HRQL score while on PPIs of 2.
• Pathologic acid exposure time, a baseline pH <4.0 for ≥ 5.3% of time during a 48-hour evaluation period.
• Twenty two years of age or older.
• Life expectancy of at least two years.
• Willing and able to return to the clinic or hospital for all evaluation procedures scheduled throughout the course of this study.
• Is capable of understanding clinical study procedures and giving informed consent.

Exclusion Criteria: 

• Unable to tolerate an endoscopic procedure.
• Presence of esophageal or gastric varices.
• Presence of erosive esophagitis (LA Classification of C or D).
• Presence of a hiatal hernia > 2 cm.
• Presence of Barrett's esophagus.
• Presence of esophageal motility disorder.
• History of or known esophageal stricture or gross esophageal anatomic abnormalities.
• Symptoms of dysphagia more than once per week within the last six months.
• Obesity (BMI ≥ 35).
• Gastric or esophageal cancer undergoing active treatment. 
• Received radiation therapy to the esophagus and has fibrosis of the tissue at the likely injection sites. 
• Had an ablation procedure in the lower esophageal sphincter area. 
• Has a condition that could lead to significant postoperative complications, including current infection, anticoagulant use, uncontrolled diabetes or autoimmune disorder.
• Enrolled in a concurrent clinical trial.
• Inability to comply with study protocol due to a chronic disease, psychiatric illness, alcoholism, drug abuse, or geographic distance (as determined by investigator). 
• Pregnant and/or given birth in the previous twelve months or who plan to become pregnant in the next twelve months Prior gastric or GERD surgery.