Evidence map›Paper›PMID 39822054›Full record

Trial reportOtolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery2025

Temperature-Controlled Radiofrequency Treatment of the Nasal Valve in Patients With Nasal Obstruction: Long-Term Outcomes.

Joseph K Han, Jon N Rosenthal, Chad M McDuffie, David M Yen, Nadim B Bikhazi, Venkata Vasu Kakarlapudi, Stacey L Silvers

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04549545 (The Vivaer® Procedure for Treatment of Nasal Airway Obstruction - A ProspecTive, Multicenter Randomized Controlled TriAl Comparing Vivaer to Sham Control), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04549545 nacompletednot on this map

The Vivaer® Procedure for Treatment of Nasal Airway Obstruction - A ProspecTive, Multicenter Randomized Controlled TriAl Comparing Vivaer to Sham Control (VATRAC)

TypeinterventionalSponsorAerin MedicalRan2020 to 2025Enrolled119ConditionsNasal Airway ObstructionArmsVivaer ARC Stylus, Sham
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Joseph K HanDepartment of Otolaryngology-Head and Neck Surgery, Eastern Virginia Medical School, Norfolk, Virginia, USA.
Jon N RosenthalENT and Allergy Associates of Florida, Coral Springs, Florida, USA.
Chad M McDuffieENT Associates of Texas, McKinney, Texas, USA.
David M YenSpecialty Physician Associates, Bethlehem, Pennsylvania, USA.
Nadim B BikhaziOgden Clinic, Ogden, Utah, USA.
Venkata Vasu KakarlapudiAdvanced ENT and Allergy, New Albany, Indiana, USA.
Stacey L SilversMadison ENT & Facial Plastic Surgery, New York, New York, USA.

Funding

Aerin Medical
6 · The paper itself

Abstract

objectiveTo evaluate the efficacy, safety, and durability of temperature-controlled radiofrequency (TCRF) treatment of the nasal valve in patients with severe or extreme nasal airway obstruction (NAO). STUDY

designA long-term, prospective, multicenter, single-blind, randomized controlled trial.

settingSixteen otolaryngologic clinics and academic centers.

methodsPatients received TCRF treatment on the lateral nasal valve. All patients were followed through 3 years. Outcome measures included the Nasal Obstruction Symptom Evaluation (NOSE) Scale, Epworth Sleepiness Scale (ESS), and adverse events (AEs). Treatment responders were defined as a ≥1 reduction in severity class or ≥20% reduction in NOSE score.

resultsOut of 108 patients who received TCRF treatment, 54 reached the 3-year follow-up timepoint. The baseline mean NOSE score was 76.3 (95% confidence interval [CI], 73.6 to 79.1). The 3-year NOSE score treatment effect was -49.4 ([95% CI, -56.5 to -42.4]; P < .001) a 64.7% improvement from baseline; 88.7% of patients were responders. Most patients reported significant improvements in sleep post-treatment with a mean ESS score of 4.5 (95% CI, 3.4 to 5.7) at 3 years compared to 10.3 (95% CI, 9.2 to 11.4) at baseline.

conclusionTreatment with the TCRF device for nasal valve obstruction resulted in sustained improvements in nasal obstruction symptoms and sleep quality over a 3-year period without any serious AEs. These findings support the long-term benefits and sustained improvements in symptoms in patients with NAO.

Indexed as

Nasal ObstructionRadiofrequency AblationAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedProspective StudiesSingle-Blind MethodTreatment Outcomenasal airway obstructionnasal valve dysfunctionsleep obstructiontemperature‐controlled radiofrequency

Identifiers

PMID39822054
PMCPMC11947858

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.