NCT03793218

Alar Batten Graft vs Latera for Nasal Valve Collapse

Withdrawn NA Last updated 11 January 2024

What this trial tests

NA trial testing Latera Device in Nasal Valve Incompetence. Withdrawn.

Timeline

28 August 2018

Primary endpoint
1 September 2019

1 September 2019

Quick facts

Lead sponsor	University of Virginia
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Start date	28 August 2018
Primary completion	1 September 2019
Estimated completion	1 September 2019

Drugs / interventions tested

• Latera Device
• Alar Batten Graft

Conditions studied

• Nasal Valve Incompetence — all drugs for Nasal Valve Incompetence →

Sponsor

University of Virginia

Who can join

18 and older, any sex, with Nasal Valve Incompetence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Nasal obstruction is a common complaint for the patient presenting to the Otolaryngologist and/or the Facial Plastic surgeon. There are numerous potential causes of nasal obstruction, with more easily addressed pathologies such as posterior septal deviation and inferior turbinate hypertrophy often being over-diagnosed. Nasal valve obstruction, particularly dynamic nasal sidewall collapse, is of significant interest to the rhinoplasty surgeon. Traditionally, collapse of the nasal sidewall has been addressed via structural cartilage grafting, with alar batten grafting being the most commonly used method to provide support to the weak nasal sidewall. Recently, an absorbable nasal implant, comprised of a polylactic acid copolymer, has been advocated for supporting the nasal sidewall and relieving nasal obstruction. There are several proposed advantages of the implant over traditional operative techniques, namely the ease of endonasal insertion, which can be performed in the outpatient clinic setting. Preliminary investigations demonstrate subjective improvement in nasal obstruction with use of the implant, however, there has been no direct comparison with traditional techniques utilizing cartilage grafting.

This study is being done at both UVa and in Oregon. This prospective study will randomize patients with nasal obstruction and documented dynamic nasal sidewall collapse into one of two groups undergoing treatment with either endonasal batten grafting or the absorbable Latera nasal valve implant. Preoperative and postoperative nasal obstruction will be assessed with a validated survey for nasal obstructive symptoms, the Nasal Obstruction Symptom Evaluation (NOSE) score. The mean preoperative and postoperative NOSE score between the groups will be compared at 1, 6, 12, and 24 months post-operatively to compare the efficacy of both techniques. Subjects will be blinded to the surgical intervention they receive.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.