Novel Endoluminal Clinical TreAtment of Reflux

Status unconfirmed · Not applicable

Conditions studied: GERD

In brief

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.

Key facts

Study ID

NCT03090607

Run by

Impleo Medical Inc.

People needed

100

Starts

2017-11-01

Expected to finish

2022-07-01

Last updated by the study team

2020-03-12

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Keck School of Medicine of USC — Los Angeles, California, United States
• Digestive Health Center — Palo Alto, California, United States
• SOFI - Center for Esophageal Wellness — Englewood, Colorado, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• Esophageal Institute of Atlanta — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Washington University in Saint Louis — St Louis, Missouri, United States
• The Oregon Clinic, Gastrointestinal and Minimally Invasive Surgery Division — Portland, Oregon, United States
• Aurora Medical Center Summit — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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