ArticleInternational forum of allergy & rhinology2026
Temperature-Controlled Radiofrequency for Severe Nasal Airway Obstruction: A Non-Inferiority Comparison With Surgical Intervention.
Article in International forum of allergy & rhinology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06922955 (A Prospective, Open-label, Multi-center, Non-inferiority Study Comparing VivAer® to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction), which is not on this map. Not yet cited in PubMed.
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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.
A Prospective, Open-label, Multi-center, Non-inferiority Study Comparing VivAer® to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction (The CompAer Study).
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14 authors.
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Abstract
introductionTemperature-controlled radiofrequency (TCRF), septoplasty (ST) with turbinate reduction, and functional rhinoplasty (FR) are treatment options for nasal airway obstruction (NAO) and nasal valve dysfunction (NVD), but no direct comparison of these procedures has been performed.
methodsThis prospective, open-label, non-inferiority (NI) trial, conducted at 29 US sites, used a prespecified NI margin and inverse probability of treatment weighting to simulate randomization and facilitate an unbiased comparison of TCRF to ST and FR in adults with Nasal Obstruction Symptom Evaluation scores ≥ 55 and NVD. NI was determined using a 15% difference in the 3-month responder rate (≥ 24-point NOSE score improvement) for TCRF compared to ST and FR. Additional analyses included return to work/regular activities (RTW) and adverse events (AEs).
resultsA total of 174 patients were treated (116 TCRF and 58 surgery [35 ST, 23 FR]). At 3 months, TCRF was non-inferior to surgery with a 90.5% responder rate compared to 94.3% for ST (mean difference: 0.04 [95% CI, -0.02 to 0.11]; p < 0.001) and 95.7% for FR (mean difference: -0.12 [95% CI, -0.23 to 0]; p < 0.001). TCRF median RTW was 1 day versus 5.5 and 7.5 days for ST and FR, respectively. TCRF had fewer AEs than surgery (6.9% TCRF patients vs. 19.0% for surgical arms combined).
conclusionsTCRF patient treatment response was non-inferior to ST and FR, with fewer AEs and faster RTW. These findings support TCRF as a minimally invasive alternative to nasal surgery for patients with NAO and NVD.
trial registrationClinicalTrials.gov identifier: NCT06922955.
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