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

NCT02952313 | Completed Results

• 1 other identifier: SPI-CP-301
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 12

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.

Conditions

Nasal Obstruction

Outcome Measures

Primary Outcomes (2)

• The Primary Efficacy Endpoint is the Percent of Treatment Responders

  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).

  6 months post procedure

• Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events

  Number of participants with a device-related or procedure-related adverse event

  6 months post procedure

Secondary Outcomes (4)

• Percent of Treatment Responders

  1, 3 12, 18, and 24 months post procedure.

• Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS).

  1, 3, 6, 12, 18, and 24 months post procedure

• Subject Satisfaction Questionnaire

  6 months

• Procedure and Device Related Adverse Events

  After 6 months and up to 24 months post procedure

Study Arms (1)

Latera Implant

OTHER

All participants have unilateral or bilateral placement of LATERA Nasal Implants.

Device: Nasal Implant

Interventions

Nasal Implant DEVICE

Latera Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has Nasal Obstruction Symptom Evaluation (NOSE) Score ≥55.
• The subject has dynamic lateral nasal wall insufficiency as confirmed by Positive Modified Cottle Maneuver22.
• 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 nasal Implant procedure alone or with septoplasty and/or a turbinate reduction procedure in an operating room setting.
• The subject has appropriate nasal and facial anatomy to receive Latera Implant.
• The subject agrees to follow-up examinations through twelve (12) months post operatively.
• 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.

You may not qualify if:

• The subject is having a concurrent Functional Endoscopic Sinus Surgery (FESS) or sinuplasty.
• The subject has had rhinoplasty within the past twelve (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 twelve (12) months after the index procedure.
• The subject has had septoplasty and/or inferior turbinate reduction within the past six (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 non-surgical treatment of their nasal valve, other than the index procedure, within twelve (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 intra-nasal drug user.
• The subject has had a cancerous or pre-cancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy.
• 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.
• The subject has a history of a significant bleeding disorder(s) that would prevent healing of the treatment area post procedure.

Sponsors & Collaborators

• Spirox, Inc.: lead

Study Sites (12)

Beverly Hills Aesthetic Surgical Institute

Beverly Hills, California, 90210, United States

Location

ENT Assoc. of South Florida

Boca Raton, Florida, 33487, United States

Location

The Center for Sinus, Allergy & Sleep Wellness

Boynton Beach, Florida, 33472, United States

Location

ENT of Georgia

Atlanta, Georgia, 30342, United States

Location

Chicago Nasal & Sinus Center

Chicago, Illinois, 60602, United States

Location

Northwestern University

Chicago, Illinois, 606611, United States

Location

ENT New Orelans

Marrero, Louisiana, 70072, United States

Location

Madison ENT & Facial Plastic Surgery

New York, New York, 10016, United States

Location

Piedmont ENT

Winston-Salem, North Carolina, 27103, United States

Location

ENT & Allergy Center of Austin

Austin, Texas, 78746, United States

Location

Collin County ENT

Frisco, Texas, 75034, United States

Location

Ogden Clinic

Ogden, Utah, 84403, United States

Location

Related Publications (2)

• 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.

  PMID: 29756407 RESULT

• 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.

  PMID: 33853139 DERIVED

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Principal Clinical Research & Publications Manager
• Organization: Stryker ENT

ellen.omalley@stryker.com

763-463-1598

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 2, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: August 1, 2019
• Last Updated: September 1, 2020
• Results First Posted: April 23, 2019

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)