Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started Aug 2018

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1 year study duration

Study Start

First participant enrolled

August 28, 2018

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed

Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

January 2, 2019

Last Update Submit

January 9, 2024

Conditions

Nasal Valve Incompetence

Outcome Measures

Primary Outcomes (1)

12 Month NOSE Score
Mean change in Nose score at 12 month post-op visit
12 months

Secondary Outcomes (3)

1 Month NOSE Score
1 month
6 Month NOSE Score
6 months
24 Month NOSE Score
24 months

Study Arms (2)

Latera Device

EXPERIMENTAL

The LATERA (Spirox Inc., Menlo Park, CA) device, an absorbable nasal implant comprised of a 70:30 blend of poly(L-lactide) and poly(D-lactide), is designed to provide support to the upper and lower lateral cartilages, thereby correcting nasal wall collapse. The implant was first used in the US and cleared by the FDA in 2016. It is designed as a ribbed cylindrical structure with a forked distal end. The implant is delivered endonasally, with a 16-gauge catheter, lateral to the upper and lower lateral cartilages and over the ascending process of the maxilla. The forked end rests on the ascending process of the maxilla and the flexible implant provides support the nasal sidewall soft tissue and cartilage. This non-toxic, biocompatible co-polymer has an extensive use in a variety of medical devices including suture materials and implants. In vivo studies demonstrate the copolymer to reliably decompose over an 18-24 month period.

Device: Latera Device