Novel Endoluminal Clinical TreAtment of Reflux

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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GERD

Intervention / Treatment
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* Device: Aluvra™
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History 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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aluvra™<br>Endoscopic injection of bulking agent (Aluvra) to the lower esophageal sphincter | Device: Aluvra™<br>* Endoscopic injection of bulking agent to the lower esophageal sphincter<br>* Other names: injectable bulking agent for GERD;|
| Sham Comparator: Saline<br>Endoscopic injection of saline | Drug: Saline<br>* Endoscopic injection of saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Aluvra- GERD HRQL | 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. | 12 months | 
| Efficacy of Aluvra- Esophageal PH | 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. | 12 months |