Clinical trial NCT03090607: Novel Endoluminal Clinical TreAtment of Reflux
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: GERD
Lead sponsor: Impleo Medical Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of Aluvra- GERD HRQL
timeFrame: 12 months
measure: Efficacy of Aluvra- Esophageal PH
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck School of Medicine of USC
state: California
city: Palo Alto
country: United States
facility: Digestive Health Center
state: California
city: Englewood
country: United States
facility: SOFI - Center for Esophageal Wellness
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Esophageal Institute of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University in Saint Louis
state: Missouri
city: Portland
country: United States
facility: The Oregon Clinic, Gastrointestinal and Minimally Invasive Surgery Division
state: Oregon
city: Milwaukee
country: United States
facility: Aurora Medical Center Summit
state: Wisconsin
Study officials:
References: