NCT03400787

Latera RCT - Latera vs. Sham Control for Lateral Nasal Valve Collapse

Latera Randomized Controlled Trial (RCT) - Latera® Absorbable Nasal Implant vs. Sham Control for Lateral Nasal Valve Collapse

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Spirox, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the LATERA RCT is to demonstrate the superiority of the Latera Implant to improve nasal breathing, compared with a Sham Control procedure.

Detailed description

To evaluate the Latera Absorbable Nasal Implant (Latera Implant) Implant versus Sham Control in subjects with nasal valve collapse due to or primarily due to insufficient cartilaginous support of the lateral nasal wall.

Conditions

• Nasal Valve Collapse
• Nasal Breathing

Interventions

Type	Name	Description
DEVICE	Latera Implant	Treatment with implant
DEVICE	Sham Procedure	Sham procedure where the Latera delivery device is inserted but no implant delivered.

Timeline

• Start date: 2017-11-28
• Primary completion: 2019-02-01
• Completion: 2020-12-23
• First posted: 2018-01-17
• Last updated: 2021-02-09
• Results posted: 2020-01-09

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study