- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02964312
LATERA-OFFICE Study
August 20, 2020 updated by: Spirox, Inc.
Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OFFICE) Study
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 Overview
Study Type
Interventional
Enrollment (Actual)
166
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Beverly Hills, California, United States, 90210
- Beverly Hills Aesthetic Surgical Institute
-
Beverly Hills, California, United States, 90212
- Alessi Institute For Facial Plastic Surgery
-
-
Florida
-
Boca Raton, Florida, United States, 33487
- ENT Assoc. of South Florida
-
Boynton Beach, Florida, United States, 33472
- The Center for Sinus, Allergy, & Sleep Wellness
-
-
Georgia
-
Atlanta, Georgia, United States, 30342
- ENT of Georgia
-
-
Illinois
-
Chicago, Illinois, United States, 60602
- Chicago Nasal & Sinus Center
-
-
New York
-
New York, New York, United States, 10016
- Madison ENT & Facial Plastic surgery
-
-
Texas
-
Frisco, Texas, United States, 75034
- Collin County ENT
-
-
Utah
-
Ogden, Utah, United States, 84403
- Ogden Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The subject has Nasal Obstruction Symptom Evaluation (NOSE) score ≥55.
- The subject has dynamic lateral nasal wall insufficiency as confirmed by positive modified Cottle maneuver.
- The subject is ≥18 years of age.
- The subject is willing and able to provide informed consent and comply with the study protocol.
- The subject is seeking treatment for nasal airway obstruction due to nasal valve collapse (NVC) and is willing to undergo an in-office nasal implant procedure alone or with a turbinate reduction procedure.
- The subject has appropriate nasal and facial anatomy to receive the Latera Implant.
- The subject agrees to follow-up examinations through 12 months post operatively.
- The subject has failed to benefit from appropriate maximal medical management [eg, nasal steroids (at least 4 weeks); antihistamines; oral decongestants; nasal strips, stents, or cones]. Failure of maximal medical management may be from lack of effectiveness or tolerability.
Exclusion Criteria:
- The subject is having a concurrent functional endoscopic sinus surgery (FESS) or sinuplasty.
- The subject has had rhinoplasty within the past 12 months.
- The subject is planning to have other concurrent rhinoplasty procedure.
- The subject is planning to have other rhinoplasty procedures or will use external dilators within 12 months after the index procedure.
- The subject has had septoplasty and/or inferior turbinate reduction within the past 6 months.
- The subject has, in the view of the clinician, inappropriate fixation on their nasal airway.
- The subject plans to have any surgical or nonsurgical treatment of their nasal valve, other than the index procedure, within 12 months of the study.
- The subject has a permanent Implant or dilator in the nasal area.
- The subject has concomitant inflammatory or infectious skin conditions or unhealed wounds in the treatment area.
- The subject currently has active nasal vestibulitis.
- The subject has a history of nasal vasculitis.
- The subject is a chronic systemic steroid or recreational intranasal drug user.
- The subject has had a cancerous or precancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy.
- The subject has polyps or pathology (ie, septal deviation) other than turbinate hypertrophy and/or lateral wall insufficiency that would contribute to airway obstruction.
- The subject has a history of a significant bleeding disorder(s) that would prevent healing of the treatment area post procedure.
- The subject has a known or suspected allergy to polylactide polymer (PLA) or other absorbable materials.
- The subject has a significant systemic disease such as poorly controlled diabetes which, in the investigator's opinion, could predispose the subject to poor wound healing.
- The subject is currently using nasal oxygen or continuous positive airway pressure (CPAP).
- The subject is not a candidate for procedures conducted under local anesthesia and/or managed anesthesia care (MAC) or conscious sedation.
- Female subjects of childbearing potential, known or suspected to be pregnant, or is lactating.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Latera Implant
Unilateral or bilateral placement of the Latera nasal implant for support of the lateral nasal wall cartilage.
|
Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure in an office setting under local anesthesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
6 months
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
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).
|
1, 3, 12, 18, and 24 months post procedure.
|
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.
|
1, 3, 6, 12, 18, and 24 months post procedure
|
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.
|
After 6 months and up to 12 months post procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Douglas Sidle, MD, Northwestern University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Stolovitzky P, Sidle DM, Ow RA, Nachlas NE, Most SP. A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant. Laryngoscope. 2018 Nov;128(11):2483-2489. doi: 10.1002/lary.27242. Epub 2018 May 14.
- Sidle DM, Stolovitzky P, O'Malley EM, Ow RA, Nachlas NE, Silvers S. Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures. Facial Plast Surg. 2021 Oct;37(5):673-680. doi: 10.1055/s-0041-1726464. Epub 2021 Apr 14.
- Sidle DM, Stolovitzky P, Ow RA, Silvers S, Matheny K, Bikhazi N, Wani M, Scurry WC, Most SP. Twelve-month outcomes of a bioabsorbable implant for in-office treatment of dynamic nasal valve collapse. Laryngoscope. 2020 May;130(5):1132-1137. doi: 10.1002/lary.28151. Epub 2019 Jun 28.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 10, 2016
Primary Completion (Actual)
March 21, 2018
Study Completion (Actual)
August 29, 2019
Study Registration Dates
First Submitted
November 11, 2016
First Submitted That Met QC Criteria
November 15, 2016
First Posted (Estimate)
November 16, 2016
Study Record Updates
Last Update Posted (Actual)
September 3, 2020
Last Update Submitted That Met QC Criteria
August 20, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPI-CP-302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nasal Obstruction
-
Spirair, IncRecruitingNasal Airway Obstruction | Nasal Septal DeviationUnited States
-
Aerin MedicalOhio State UniversityCompletedNasal ObstructionUnited States
-
Medtronic Surgical TechnologiesCompletedNasal Airway ObstructionUnited States, Canada
-
Aerin MedicalActive, not recruitingNasal ObstructionUnited States
-
Aerin MedicalActive, not recruitingNasal Airway ObstructionUnited States
-
New York City Health and Hospitals CorporationUnknownNasal Airway ObstructionUnited States
-
Yuzuncu Yıl UniversityCompleted
-
Aerin MedicalCompletedNasal ObstructionUnited States
-
Aerin MedicalCompleted
-
HNO-Praxis Alte PostAerin MedicalCompletedNasal Obstruction, BilateralGermany
Clinical Trials on Nasal Implant
-
Spirox, Inc.CompletedNasal ObstructionUnited States
-
Spirox, Inc.CompletedNasal Valve CollapseGermany
-
University of RochesterTerminatedChronic Rhinosinusitis (Diagnosis)United States
-
Intersect ENTCompletedChronic Sinusitis | Nasal PolypsUnited States
-
Arab American University (Palestine)CompletedDental Implant TherapyPalestinian Territory, occupied
-
Intersect ENTCompletedChronic Sinusitis | Nasal PolyposisUnited States
-
Aula Dental AvanzadaRecruiting
-
University of Sao PauloCompletedCataract | AstigmatismBrazil
-
Aula Dental AvanzadaCompleted