Novel Endoluminal Clinical TreAtment of Reflux
NECTAR
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
1 other identifier
interventional
100
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2017
CompletedFirst Posted
Study publicly available on registry
March 27, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedMarch 12, 2020
March 1, 2020
3.7 years
March 15, 2017
March 10, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Aluvra™
EXPERIMENTALEndoscopic injection of bulking agent (Aluvra) to the lower esophageal sphincter
Saline
SHAM COMPARATOREndoscopic injection of saline
Interventions
Eligibility Criteria
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)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Keck School of Medicine of USC
Los Angeles, California, 90033, United States
Digestive Health Center
Palo Alto, California, 94304, United States
SOFI - Center for Esophageal Wellness
Englewood, Colorado, 80113, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Esophageal Institute of Atlanta
Atlanta, Georgia, 30309, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Washington University in Saint Louis
St Louis, Missouri, 63110, United States
The Oregon Clinic, Gastrointestinal and Minimally Invasive Surgery Division
Portland, Oregon, 97213, United States
Aurora Medical Center Summit
Milwaukee, Wisconsin, 53066, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2017
First Posted
March 27, 2017
Study Start
November 1, 2017
Primary Completion
July 1, 2021
Study Completion
July 1, 2022
Last Updated
March 12, 2020
Record last verified: 2020-03