Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial.

ABSTRACT:

Background

Dynamic nasal valve collapse (NVC) is a common factor contributing to nasal obstruction; however, it is often underdiagnosed and untreated. An in-office, minimally invasive procedure addressing dynamic NVC uses a bioabsorbable implant (Latera) to support the lateral nasal wall. This study aimed to evaluate the safety and effectiveness of the treatment in a randomized controlled trial (RCT) with sham control.

Methods

In this prospective, multicenter, single-blinded RCT, 137 patients from 10 clinics were randomized into 2 arms: treatment arm (70 patients) and sham control arm (67 patients). Outcome measures were followed through 3 months after the procedure. The primary endpoint was the responder rate (percentage of patients with reduction in clinical severity by ≥1

SUBMITTER: Stolovitzky P 

PROVIDER: S-EPMC6771676 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature