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Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study

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ClinicalTrials.gov Identifier: NCT02952313
Recruitment Status : Completed
First Posted : November 2, 2016
Results First Posted : April 23, 2019
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Spirox, Inc.

Brief Summary:
This study is being conducted to obtain outcomes data in subjects with severe to extreme class NOSE scores undergoing placement of the Spirox Latera Implant with or without concurrent septoplasty and/or turbinate reduction procedures in an operating room setting.

Condition or disease Intervention/treatment Phase
Nasal Obstruction Device: Nasal Implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Latera Implant
All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Device: Nasal Implant



Primary Outcome Measures :
  1. 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).

  2. 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


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject has Nasal Obstruction Symptom Evaluation (NOSE) Score ≥55.
  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:

  1. The subject is having a concurrent Functional Endoscopic Sinus Surgery (FESS) or sinuplasty.
  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.

Information from the National Library of Medicine

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


Locations
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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
Northwestern University
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
Piedmont ENT
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 Clinic
Ogden, Utah, United States, 84403
Sponsors and Collaborators
Spirox, Inc.
  Study Documents (Full-Text)

Documents provided by Spirox, Inc.:
Study Protocol  [PDF] September 7, 2017
Statistical Analysis Plan  [PDF] January 3, 2018

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Spirox, Inc.
ClinicalTrials.gov Identifier: NCT02952313    
Other Study ID Numbers: SPI-CP-301
First Posted: November 2, 2016    Key Record Dates
Results First Posted: April 23, 2019
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Nasal Obstruction
Nose Diseases
Respiratory Tract Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Otorhinolaryngologic Diseases