GERD
Conditions
Brief summary
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.
Interventions
DEVICEAluvra™
Endoscopic injection of bulking agent to the lower esophageal sphincter
DRUGSaline
Endoscopic injection of saline
Sponsors
Impleo Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Aluvra- GERD HRQL | 12 months | Efficacy will be established through two co-primary objectives. The first co-primary endpoint will be to compare response rates between treatment group and control group at 12 months based on the GERD-Health Related Quality of Life questionnaire. |
| Efficacy of Aluvra- Esophageal PH | 12 months | Efficacy will be established through two co-primary objectives. The second co-primary endpoint will be to compare change from baseline in total percent time esophageal pH \<4 between the treatment group vs. the sham control group at 12 months. |
Countries
United States
Outcome results
None listed