Novel Endoluminal Clinical TreAtment of Reflux | NCT03090607

NCT03090607

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aluvra™	Experimental	Endoscopic injection of bulking agent (Aluvra) to the lower esophageal sphincter	Device: Aluvra™
Saline	Sham Comparator	Endoscopic injection of saline	Drug: Saline

Name	Type	Description	Arm Group Labels	Other Names
Aluvra™	Device	Endoscopic injection of bulking agent to the lower esophageal sphincter	Aluvra™

Outcomes Module

Primary Outcomes

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

Eligibility Module

Eligibility Criteria

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

Facility	Status	City	State	ZIP	Country	Contacts
Keck School of Medicine of USC		Los Angeles	California	90033	United States
Digestive Health Center

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases