Novel Endoluminal Clinical TreAtment of Reflux
Trial ID or NCT#
This is a prospective, multi-center, double-blind, crossover, randomized controlled trial designed to demonstrate the safety and efficacy of Aluvra for the treatment of GERD.
A 12-month Double-blind, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Efficacy of Endoluminal Aluvra™ for the Treatment of Gastroesophageal Reflux Disease
- 1. History of heartburn-like pain, regurgitation, or both prior to the initiation of proton pump inhibitor (PPIs) therapy.
- 2. History of GERD symptoms of at least six months despite continuous PPIs.
- 3. GERD-HRQL score ≥15 after discontinuing PPI therapy.
- 4. GERD-HRQL score improvement of at least 6 points while on PPIs, with at least 4-point improvement in heartburn subscore.
- 5. A minimum GERD-HRQL score while on PPIs of 2.
- 6. Pathologic acid exposure time, a baseline pH <4.0 for ≥ 5.3% of time during a 48-hour evaluation period.
- 7. Twenty two years of age or older.
- 8. Life expectancy of at least two years.
- 9. Willing and able to return to the clinic or hospital for all evaluation procedures scheduled throughout the course of this study.
- 10. Is capable of understanding clinical study procedures and giving informed consent.
- 1. Unable to tolerate an endoscopic procedure
- 2. Presence of esophageal or gastric varices
- 3. Presence of erosive esophagitis (LA Classification of C or D)
- 4. Presence of a hiatal hernia > 2 cm
- 5. Presence of Barrett's esophagus
- 6. Presence of esophageal motility disorder
- 7. History of or known esophageal stricture or gross esophageal anatomic abnormalities
- 8. Symptoms of dysphagia more than once per week within the last six months
- 9. Obesity (BMI ≥ 35)
- 10. Gastric or esophageal cancer undergoing active treatment
- 11. Received radiation therapy to the esophagus and has fibrosis of the tissue at the likely injection sites
- 12. Had an ablation procedure in the lower esophageal sphincter area
- 13. Has a condition that could lead to significant postoperative complications, including current infection, anticoagulant use, uncontrolled diabetes or autoimmune disorder
- 14. Enrolled in a concurrent clinical trial
- 15. Inability to comply with study protocol due to a chronic disease, psychiatric illness, alcoholism, drug abuse, or geographic distance (as determined by investigator)
- 16. Pregnant and/or given birth in the previous twelve months or who plan to become pregnant in the next twelve months
- 17. Prior gastric or GERD surgery
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