NCT03083106

Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Zelegent, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Safety \& Efficacy Study

Detailed description

Evaluate the safety and efficacy of the Zelegent, Inc. Elevo™ Kit Snoring Intervention Device (a minimally invasive, barbed, absorbable suture implant) in the reduction of simple snoring through subjective evaluation of snoring and objective snoring sound analysis. The Zelegent, Inc. Elevo™ Kit Snoring Intervention Device is intended to reduce or eliminate simple snoring in the target patient population via minimally invasive implantation of specialized barbed, absorbable sutures in the soft palate for the purpose of stiffening by way of shortening and lifting the soft palate thereby addressing the root cause of snoring.

Conditions

• Snoring

Interventions

Type	Name	Description
DEVICE	Elevoplasty	The Elevo™ Kit Snoring Intervention Device is designed to facilitate deployment of the Elevo™ suture implant into the submucosal tissue of the soft palate via a minimally invasive, outpatient procedure performed by an otolaryngologist in a medical office setting.

Timeline

• Start date: 2017-03-03
• Primary completion: 2017-09-29
• Completion: 2017-09-29
• First posted: 2017-03-17
• Last updated: 2020-01-30

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study