Temperature-controlled radiofrequency ablation for the treatment of chronic rhinitis: Two-year outcomes from a prospective multicenter trial.

Background: Minimally invasive temperature-controlled radiofrequency (TCRF) ablation of the posterior nasal nerve (PNN) demonstrated a significant larger treatment effect on the symptom burden of chronic rhinitis patients than a sham control (no energy delivery) at the 3-month primary endpoint of this trial.

Methods: Two-year posttreatment outcomes for patients treated in a prospective, multicenter, patient-blinded randomized controlled trial were determined by combining the index active treatment-arm and index control-arm crossover patients into a single group (after the primary endpoint) to evaluate the treatment effect durability and long-term effects on concomitant chronic rhinitis medication usage.

Results: The mean baseline reflective total nasal symptom score (rTNSS) was 8.

Outcomes 12 Months After Temperature-Controlled Radiofrequency Device Treatment of the Nasal Valve for Patients With Nasal Airway Obstruction.

Importance: Nasal valve collapse is a primary cause of nasal airway obstruction (NAO). Patients with NAO and nasal valve collapse experience a variety of symptoms that lower their quality of life, such as nasal congestion, headache, sleep disturbance, daytime sleepiness, and snoring.

Objective: To determine if active treatment of the nasal valve with a temperature-controlled radiofrequency (TCRF) device, previously demonstrated superior to a sham procedure at 3 months, was safe and associated with sustained improvements in symptoms of NAO through 12 months.

Temperature-controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12-month outcomes after treatment in a randomized controlled trial.

Background: Temperature-controlled radiofrequency (TCRF) neurolysis of the posterior nasal nerve (PNN) area for the treatment of chronic rhinitis was previously reported as superior to a sham-control procedure at 3 months postprocedure in a randomized controlled trial (RCT). The primary endpoint was a responder rate of ≥30% improvement (decrease) for 24-hour reflective total nasal symptom score (rTNSS) compared with baseline. Herein, 12-month outcomes after active treatment are reported.

Effect of Radiofrequency Neurolysis on the Symptoms of Chronic Rhinitis: A Randomized Controlled Trial.

Objective: To determine the safety and efficacy of temperature-controlled radiofrequency (RF) neurolysis of the posterior nasal nerve (PNN) area for the treatment of chronic rhinitis.

Study Design: A multicenter, prospective, single-blinded, randomized controlled trial, in which the control arm underwent a sham procedure.

Setting: Sixteen otolaryngology centers.

Temperature-controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial.

Background: Nasal valve collapse is one of several causes of nasal obstruction. The safety and efficacy of a temperature-controlled radiofrequency (RF) device for the treatment of the nasal valve for nasal airway obstruction (NAO) has been established in single-arm studies. The objective of this trial was to compare active device treatment against a sham procedure (control).

A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps.

Background: Topical intranasal corticosteroid sprays (INCSs) are standard treatment for nasal polyps (NPs), but their efficacy is reduced by poor patient compliance and impaired access of drug to the sinus mucosa. A corticosteroid-eluting sinus implant was designed to address these limitations in patients with recurrent polyposis after sinus surgery by delivering 1350 μg of mometasone furoate (MF) directly to the ethmoid sinus mucosa over approximately 90 days.

Methods: A randomized, sham-controlled, double-blind trial was undertaken in 300 adults with refractory chronic rhinosinusitis with NPs (CRSwNP), who were candidates for repeat surgery.

Office-Based Balloon Sinus Dilation: 1-Year Follow-up of a Prospective, Multicenter Study.

Objective: Balloon sinus dilation (BSD) instruments afford the opportunity for office-based sinus procedures in properly selected patients with chronic rhinosinusitis (CRS). This study evaluated patient-reported outcomes 1 year after office-based BSD.

Methods: Adult patients with medically refractory CRS were prospectively enrolled into a multicenter, single-arm study and treated with office-based BSD under local anesthesia.

Prospective, open-label, 18-month trial of calcium hydroxylapatite (Radiesse) for facial soft-tissue augmentation in patients with human immunodeficiency virus-associated lipoatrophy: one-year durability.

Background: The objective was to evaluate the safety and effectiveness of soft-tissue augmentation of calcium hydroxylapatite (Radiesse) in patients with facial lipoatrophy secondary to human immunodeficiency virus disease.

Methods: This 18-month, prospective, open-label, multicenter clinical trial of calcium hydroxylapatite for soft-tissue augmentation of patients with facial lipoatrophy enrolled 100 subjects (94 men and six women).

Results: Correction of facial lipoatrophy was evaluated by comparing changes from baseline using the Global Aesthetic Improvement Scale, with confirmation using standardized photography.