Prospective, multicenter, nonrandomized, single-arm controlled study to obtain outcomes data in participants with severe to extreme class NOSE scores who are undergoing placement of the Spirox Latera Implant with or without concurrent turbinate reduction procedures in an office setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
166
Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure in an office setting under local anesthesia.
Beverly Hills Aesthetic Surgical Institute
Beverly Hills, California, United States
Alessi Institute For Facial Plastic Surgery
Beverly Hills, California, United States
ENT Assoc. of South Florida
Boca Raton, Florida, United States
Efficacy: Percent of Treatment Responders
A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from 0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100).
Time frame: 6 months
Safety: Procedure- and/or Device-related Adverse Events
Number of participants with 1 or more adverse events that are determined to be related to the Latera implant and/or procedure.
Time frame: 6 months
Percent of Treatment Responders
A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from 0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100).
Time frame: 1, 3, 12, 18, and 24 months post procedure.
Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS)
Change from baseline in the nasal obstryction VAS score. Participants provide scores on a scale of 0 (easy to breathe through the nose) to 100 (difficult to breathe through the nose) using a 100-mm line with 1-mm increments). Negative values indicate improvement in symptoms.
Time frame: 1, 3, 6, 12, 18, and 24 months post procedure
Subject Satisfaction Questionnaire
Participants rate whether they are satisfied or not satisfied with the procedure and cosmetic appearance after the procedure. The percent of participants reporting satisfaction with the procedure is reported.
Time frame: 6 months
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The Center for Sinus, Allergy, & Sleep Wellness
Boynton Beach, Florida, United States
ENT of Georgia
Atlanta, Georgia, United States
Chicago Nasal & Sinus Center
Chicago, Illinois, United States
Madison ENT & Facial Plastic Surgery
New York, New York, United States
Collin County ENT
Frisco, Texas, United States
Ogden Clinic
Ogden, Utah, United States
Procedure and Device-related Adverse Events
Number of participants who experience procedure- or device-related adverse events.
Time frame: After 6 months and up to 12 months post procedure