Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study
NCT ID: NCT02952313
Last Updated: 2020-09-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
113 participants
INTERVENTIONAL
2016-09-30
2019-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Latera Implant
All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Nasal Implant
Interventions
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Nasal Implant
Eligibility Criteria
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Inclusion Criteria
2. The subject has dynamic lateral nasal wall insufficiency as confirmed by Positive Modified Cottle Maneuver22.
3. The subject is ≥18 years of age.
4. The subject is willing and able to provide informed consent and comply with the study protocol.
5. The subject is seeking treatment for nasal airway obstruction due to Nasal Valve Collapse (NVC) and is willing to undergo nasal Implant procedure alone or with septoplasty and/or a turbinate reduction procedure in an operating room setting.
6. The subject has appropriate nasal and facial anatomy to receive Latera Implant.
7. The subject agrees to follow-up examinations through twelve (12) months post operatively.
8. The subject has failed a trial of appropriate maximal medical management \[e.g., nasal steroids (at least 4 weeks); antihistamines; oral decongestants; nasal strips, stents, or cones\]. Failure of maximal medical management may be from lack of effectiveness or inability of subject to tolerate.
Exclusion Criteria
2. The subject has had rhinoplasty within the past twelve (12) months.
3. The subject is planning to have other concurrent rhinoplasty procedure.
4. The subject is planning to have other rhinoplasty procedures or will use external dilators within twelve (12) months after the index procedure.
5. The subject has had septoplasty and/or inferior turbinate reduction within the past six (6) months.
6. The subject has, in the view of the clinician, inappropriate fixation on their nasal airway.
7. The subject plans to have any surgical or non-surgical treatment of their nasal valve, other than the index procedure, within twelve (12) months of the study.
8. The subject has a permanent Implant or dilator in the nasal area.
9. The subject has concomitant inflammatory or infectious skin conditions or unhealed wounds in the treatment area.
10. The subject currently has active nasal vestibulitis.
11. The subject has a history of nasal vasculitis.
12. The subject is a chronic systemic steroid or recreational intra-nasal drug user.
13. The subject has had a cancerous or pre-cancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy.
14. The subject has polyps or pathology other than septal deviation and/or turbinate hypertrophy and/or lateral wall insufficiency that would contribute to airway obstruction.
15. The subject has a history of a significant bleeding disorder(s) that would prevent healing of the treatment area post procedure.
16. The subject has a known or suspected allergy to poly lactic acid (PLA) or other absorbable materials.
17. The subject has a significant systemic disease such as poorly controlled diabetes which, in the investigator's opinion, could pre-dispose the subject to poor wound healing.
18. The subject is currently using nasal oxygen or continuous positive airway pressure (CPAP).
19. The subject is not a candidate for procedures conducted under general anesthesia, managed anesthesia care (MAC) or conscious sedation.
20. If female, subject is known or suspected to be pregnant or is lactating.
18 Years
ALL
No
Sponsors
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Spirox, Inc.
INDUSTRY
Responsible Party
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Locations
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Beverly Hills Aesthetic Surgical Institute
Beverly Hills, California, United States
ENT Assoc. of South Florida
Boca Raton, Florida, United States
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
Northwestern University
Chicago, Illinois, United States
ENT New Orelans
Marrero, Louisiana, United States
Madison ENT & Facial Plastic Surgery
New York, New York, United States
Piedmont ENT
Winston-Salem, North Carolina, United States
ENT & Allergy Center of Austin
Austin, Texas, United States
Collin County ENT
Frisco, Texas, United States
Ogden Clinic
Ogden, Utah, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SPI-CP-301
Identifier Type: -
Identifier Source: org_study_id
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