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

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.

Study Overview

• Status: Unknown
• Conditions: GERD
• Intervention / Treatment: Device: Aluvra™; Drug: Saline

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Keck School of Medicine of USC
    • Palo Alto, California, United States, 94304
      • Digestive Health Center
  • Colorado
    • Englewood, Colorado, United States, 80113
      • SOFI - Center for Esophageal Wellness
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Esophageal Institute of Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in Saint Louis
  • Oregon
    • Portland, Oregon, United States, 97213
      • The Oregon Clinic, Gastrointestinal and Minimally Invasive Surgery Division
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53066
      • Aurora Medical Center Summit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aluvra™; Endoscopic injection of bulking agent (Aluvra) to the lower esophageal sphincter	Device: Aluvra™; Endoscopic injection of bulking agent to the lower esophageal sphincter; Other Names: injectable bulking agent for GERD
Sham Comparator: Saline; Endoscopic injection of saline	Drug: Saline; Endoscopic injection of saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Impleo Medical Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: NECTAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes