Novel Endoluminal Clinical TreAtment of Reflux (NECTAR)

Impleo Medical

Status: Unknown

Conditions: GERD

Treatments: Device: Aluvra™; Drug: Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT03090607

NECTAR

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Aluvra™

Experimental group

Description:

Endoscopic injection of bulking agent (Aluvra) to the lower esophageal sphincter

Treatment:

Device: Aluvra™

Saline

Sham Comparator group

Description:

Endoscopic injection of saline

Treatment:

Drug: Saline