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LATERA-OFFICE Study

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ClinicalTrials.gov Identifier: NCT02964312
Recruitment Status : Completed
First Posted : November 16, 2016
Results First Posted : October 30, 2019
Last Update Posted : September 3, 2020
Sponsor:
Collaborator:
New Arch Consulting
Information provided by (Responsible Party):
Spirox, Inc.

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-arm intervention with pre/post comparison for treatment response.
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Latera Implant
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.




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  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 12 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 maneuver.
  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 an in-office nasal implant procedure alone or with a turbinate reduction procedure.
  6. The subject has appropriate nasal and facial anatomy to receive the Latera Implant.
  7. The subject agrees to follow-up examinations through 12 months post operatively.
  8. 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:

  1. The subject is having a concurrent functional endoscopic sinus surgery (FESS) or sinuplasty.
  2. The subject has had rhinoplasty within the past 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 12 months after the index procedure.
  5. The subject has had septoplasty and/or inferior turbinate reduction within the past 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 nonsurgical treatment of their nasal valve, other than the index procedure, within 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 intranasal drug user.
  13. The subject has had a cancerous or precancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy.
  14. The subject has polyps or pathology (ie, septal deviation) other than 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 polylactide polymer (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 predispose 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 local anesthesia and/or managed anesthesia care (MAC) or conscious sedation.
  20. Female subjects of childbearing potential, 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): NCT02964312


Locations
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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 Clinic
Ogden, Utah, United States, 84403
Sponsors and Collaborators
Spirox, Inc.
New Arch Consulting
Investigators
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Principal Investigator: Douglas Sidle, MD Northwestern University
  Study Documents (Full-Text)

Documents provided by Spirox, Inc.:
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: NCT02964312    
Other Study ID Numbers: SPI-CP-302
First Posted: November 16, 2016    Key Record Dates
Results First Posted: October 30, 2019
Last Update Posted: September 3, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Spirox, Inc.:
nasal valve collapse
absorbable nasal implant
Additional relevant MeSH terms:
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Nasal Obstruction
Nose Diseases
Respiratory Tract Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Otorhinolaryngologic Diseases