Novel Endoluminal Clinical TreAtment of Reflux

Not Applicable

• Conditions: GERD
• Interventions: Device: Aluvra™; Drug: Saline

• Registration Number: NCT03090607
• Lead Sponsor: Impleo Medical Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-27
• Study Start: 2017-11-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12
• Primary Completion: 2021-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aluvra™	Aluvra™	Endoscopic injection of bulking agent (Aluvra) to the lower esophageal sphincter
Saline	Saline	Endoscopic injection of saline

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (10)

Digestive Health Center; 🇺🇸 Palo Alto, California, United States

Keck School of Medicine of USC; 🇺🇸 Los Angeles, California, United States

SOFI - Center for Esophageal Wellness; 🇺🇸 Englewood, Colorado, United States

Esophageal Institute of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Aurora Medical Center Summit; 🇺🇸 Milwaukee, Wisconsin, United States

Washington University in Saint Louis; 🇺🇸 Saint Louis, Missouri, United States

The Oregon Clinic, Gastrointestinal and Minimally Invasive Surgery Division; 🇺🇸 Portland, Oregon, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States