LATERA-OFFICE Study

NCT02964312 | Completed Results FDA Device

• 1 other identifier: SPI-CP-302
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 9

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.

Conditions

Nasal Obstruction

Keywords

nasal valve collapse; absorbable nasal implant

Outcome Measures

Primary Outcomes (2)

• Efficacy: Percent of Treatment Responders

  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).

  6 months

• Safety: Procedure- and/or Device-related Adverse Events

  Number of participants with 1 or more adverse events that are determined to be related to the Latera implant and/or procedure.

  6 months

Secondary Outcomes (4)

• Percent of Treatment Responders

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

• Change in Nasal Airway Obstruction From Baseline Using a 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 12 months post procedure

Study Arms (1)

Latera Implant

OTHER

Unilateral or bilateral placement of the Latera nasal implant for support of the lateral nasal wall cartilage.

Device: Nasal Implant

Interventions

Nasal Implant DEVICE

Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure in an office setting under local anesthesia.

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

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 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 12 months after the index procedure.
• The subject has had septoplasty and/or inferior turbinate reduction within the past 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 nonsurgical treatment of their nasal valve, other than the index procedure, within 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 intranasal drug user.
• The subject has had a cancerous or precancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy.
• The subject has polyps or pathology (ie, septal deviation) other than 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
• New Arch Consulting: collaborator

Study Sites (9)

Beverly Hills Aesthetic Surgical Institute

Beverly Hills, California, 90210, United States

Location

Alessi Institute For Facial Plastic Surgery

Beverly Hills, California, 90212, 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

Madison ENT & Facial Plastic Surgery

New York, New York, 10016, United States

Location

Collin County ENT

Frisco, Texas, 75034, United States

Location

Ogden Clinic

Ogden, Utah, 84403, United States

Location

Related Publications (3)

• Sidle DM, Stolovitzky P, Ow RA, Silvers S, Matheny K, Bikhazi N, Wani M, Scurry WC, Most SP. Twelve-month outcomes of a bioabsorbable implant for in-office treatment of dynamic nasal valve collapse. Laryngoscope. 2020 May;130(5):1132-1137. doi: 10.1002/lary.28151. Epub 2019 Jun 28.

  PMID: 31254279 RESULT

• 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

Study Officials

• Douglas Sidle, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• 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

Model Details: Single-arm intervention with pre/post comparison for treatment response.

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 16, 2016
• Study Start: November 10, 2016
• Primary Completion: March 21, 2018
• Study Completion: August 29, 2019
• Last Updated: September 3, 2020
• Results First Posted: October 30, 2019

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)