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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
Sponsor:
Information provided by (Responsible Party):
Spirox, Inc.

Tracking Information
First Submitted Date  ICMJE October 31, 2016
First Posted Date  ICMJE November 2, 2016
Results First Submitted Date  ICMJE March 7, 2019
Results First Posted Date  ICMJE April 23, 2019
Last Update Posted Date September 1, 2020
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2016)
  • The primary efficacy endpoint is the proportion of treatment responders [ Time Frame: 6 months post procedure ]
    Responder is defined as subject that has at least one (1) NOSE class shift improvement or at least 20% NOSE score reduction
  • Primary Safety Endpoint: Nasal procedure and Latera™ device-related adverse events [ Time Frame: 6 months post procedure ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2020)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2016)
  • Proportion of treatment responders [ Time Frame: 1, 3 and 12 months post procedure. ]
  • Change in nasal airway obstruction from baseline using the VAS scale. [ Time Frame: 1,3, 6 and 12 months post procedure ]
  • Subject satisfaction questionnaire [ Time Frame: 6 months ]
  • Procedure and device related adverse events [ Time Frame: 12 months post procedure ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study
Official Title  ICMJE Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nasal Obstruction
Intervention  ICMJE Device: Nasal Implant
Study Arms  ICMJE Latera Implant
All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Intervention: Device: Nasal Implant
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2019)
113
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2016)
170
Actual Study Completion Date  ICMJE August 2019
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02952313
Other Study ID Numbers  ICMJE SPI-CP-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Spirox, Inc.
Study Sponsor  ICMJE Spirox, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Spirox, Inc.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP