Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02952313|
Recruitment Status : Completed
First Posted : November 2, 2016
Results First Posted : April 23, 2019
Last Update Posted : September 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Nasal Obstruction||Device: Nasal Implant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study|
|Actual Study Start Date :||September 2016|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||August 2019|
All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Device: Nasal Implant
- The Primary Efficacy Endpoint is the Percent of Treatment Responders [ Time Frame: 6 months post procedure ]Responder is defined as a participant who has improvement of at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class or at least 20% NOSE score reduction. NOSE scores. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100).
- Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events [ Time Frame: 6 months post procedure ]Number of participants with a device-related or procedure-related adverse event
- Percent of Treatment Responders [ Time Frame: 1, 3 12, 18, and 24 months post procedure. ]Responder is defined as a participant who has improvement of at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class or at least 20% NOSE score reduction. NOSE scores. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100).
- Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS). [ Time Frame: 1, 3, 6, 12, 18, and 24 months post procedure ]Change from baseline in VAS score for ability to breathe through the nose. Participants provide scores on a scale of 0 (easy to breathe through the nose) to 100 (unable to breathe through the nose). Negative values for the change from baseline indicate improvement in symptoms.
- Subject Satisfaction Questionnaire [ Time Frame: 6 months ]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.
- Procedure and Device Related Adverse Events [ Time Frame: After 6 months and up to 24 months post procedure ]Number of participants who experience procedure or device-related adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952313
|United States, California|
|Beverly Hills Aesthetic Surgical Institute|
|Beverly Hills, California, United States, 90210|
|United States, Florida|
|ENT Assoc. of South Florida|
|Boca Raton, Florida, United States, 33487|
|The Center for Sinus, Allergy & Sleep Wellness|
|Boynton Beach, Florida, United States, 33472|
|United States, Georgia|
|ENT of Georgia|
|Atlanta, Georgia, United States, 30342|
|United States, Illinois|
|Chicago Nasal & Sinus Center|
|Chicago, Illinois, United States, 60602|
|Chicago, Illinois, United States, 606611|
|United States, Louisiana|
|ENT New Orelans|
|Marrero, Louisiana, United States, 70072|
|United States, New York|
|Madison ENT & Facial Plastic Surgery|
|New York, New York, United States, 10016|
|United States, North Carolina|
|Winston-Salem, North Carolina, United States, 27103|
|United States, Texas|
|ENT & Allergy Center of Austin|
|Austin, Texas, United States, 78746|
|Collin County ENT|
|Frisco, Texas, United States, 75034|
|United States, Utah|
|Ogden, Utah, United States, 84403|