CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 137 enrolled
Drug / intervention
Latera Implant +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03400787
NCT03400787N/ACompleted

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

Spirox, Inc.·interventional·Posted Jan 17, 2018·Updated Feb 9, 2021

In Brief

A clinical study evaluating Latera Implant and Sham Procedure for Nasal Valve Collapse and Nasal Breathing. Completed, enrolled 137 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNew Arch Consulting

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 17, 2018
Enrollment StartNov 28, 2017
Primary CompletionFeb 1, 2019
Study CompletionDec 23, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.5 years ago

Interventions

Latera Implantdevice

Treatment with implant

Sham Proceduredevice

Sham procedure where the Latera delivery device is inserted but no implant delivered.