Novel Endoluminal Clinical TreAtment of Reflux

GERD Clinical Trial

— NECTAR  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03090607
• Other study ID #: NECTAR
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: July 2022

Study information

• Verified date: March 2020
• Source: Impleo Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• GERD

Intervention

Device:
• Aluvra™
Endoscopic injection of bulking agent to the lower esophageal sphincter

Drug:
• Saline
Endoscopic injection of saline

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Impleo Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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