Trials / Unknown
UnknownNCT03090607
Novel Endoluminal Clinical TreAtment of Reflux
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Impleo Medical Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Aluvra™ | Endoscopic injection of bulking agent to the lower esophageal sphincter |
| DRUG | Saline | Endoscopic injection of saline |
Timeline
- Start date
- 2017-11-01
- Primary completion
- 2021-07-01
- Completion
- 2022-07-01
- First posted
- 2017-03-27
- Last updated
- 2020-03-12
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03090607. Inclusion in this directory is not an endorsement.