|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: NCT02964312|
Recruitment Status : Completed
First Posted : November 16, 2016
Results First Posted : October 30, 2019
Last Update Posted : September 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Nasal Obstruction||Device: Nasal Implant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||166 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-arm intervention with pre/post comparison for treatment response.|
|Masking:||None (Open Label)|
|Official Title:||Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OFFICE) Study|
|Actual Study Start Date :||November 10, 2016|
|Actual Primary Completion Date :||March 21, 2018|
|Actual Study Completion Date :||August 29, 2019|
Unilateral or bilateral placement of the Latera nasal implant for support of the lateral nasal wall cartilage.
Device: Nasal Implant
Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure in an office setting under local anesthesia.
- Efficacy: Percent of Treatment Responders [ Time Frame: 6 months ]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).
- Safety: Procedure- and/or Device-related Adverse Events [ Time Frame: 6 months ]Number of participants with 1 or more adverse events that are determined to be related to the Latera implant and/or procedure.
- Percent of Treatment Responders [ Time Frame: 1, 3, 12, 18, and 24 months post procedure. ]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).
- Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS) [ Time Frame: 1, 3, 6, 12, 18, and 24 months post procedure ]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.
- 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 12 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): NCT02964312
|United States, California|
|Beverly Hills Aesthetic Surgical Institute|
|Beverly Hills, California, United States, 90210|
|Alessi Institute For Facial Plastic Surgery|
|Beverly Hills, California, United States, 90212|
|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|
|United States, New York|
|Madison ENT & Facial Plastic Surgery|
|New York, New York, United States, 10016|
|United States, Texas|
|Collin County ENT|
|Frisco, Texas, United States, 75034|
|United States, Utah|
|Ogden, Utah, United States, 84403|
|Principal Investigator:||Douglas Sidle, MD||Northwestern University|