Trial reportInternational forum of allergy & rhinology2019
Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial.
Trial report in International forum of allergy & rhinology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03400787 (Latera Randomized Controlled Trial), which is not on this map. Cited by 9 papers.
What it found
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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.
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.
Latera Randomized Controlled Trial (RCT) - Latera® Absorbable Nasal Implant vs. Sham Control for Lateral Nasal Valve Collapse
Who cites it
9 citing papers in PubMed, 26 citations in OpenAlex.
- Long-Term Follow-up from the Treatment and Crossover Arms of a Randomized Controlled Trial of an Absorbable Nasal Implant for Dynamic Nasal Valve Collapse.Facial plastic surgery : FPS · 2022Trial
- Temperature-controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial.International forum of allergy & rhinology · 2021Trial
- Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial.International forum of allergy & rhinology · 2019Trial
- Functional nasal surgery in the office-based setting.World journal of otorhinolaryngology - head and neck surgery · 2023Review
- Two-year outcomes of temperature-controlled radiofrequency device treatment of the nasal valve for patients with nasal airway obstruction.Laryngoscope investigative otolaryngology · 2023Article
- Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures.Facial plastic surgery : FPS · 2021Article
- Nasal Airflow Changes With Bioabsorbable Implant, Butterfly, and Spreader Grafts.The Laryngoscope · 2020Article
- Treating Symptomatic Midvault Soft Tissue Collapse in Revision Rhinoplasty with a Nasal Wall Implant.Plastic and reconstructive surgery. Global open · 2020Article
- New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2019.OTO openReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDynamic 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.
methodsIn 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 category or ≥20% reduction in Nasal Obstruction Symptom Evaluation [NOSE] score).
resultsBefore the procedure, there were no statistically significant differences in patient demographics and nasal obstruction symptom measures between the 2 arms. Three months after the procedure, responder rate was significantly higher for the treatment arm compared to the control (82.5% vs 54.7%, p = 0.001). Patients in the treatment arm also had a significantly greater decrease in NOSE score (-42.4 ± 23.4 vs -22.7 ± 27.9, p < 0.0001) and significantly lower visual analogue scale (VAS) scores (-39.0 ± 29.7 vs -13.3 ± 30.0, p < 0.0001) than the sham control arm. Seventeen patients reported 19 procedure/implant-related adverse events, all of which resolved with no clinical sequelae.
conclusionOur study shows the safety and effectiveness of the bioabsorbable implant in reducing patients' nasal obstruction symptoms.
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