LATERA-OFFICE Study

Nasal Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02964312
• Other study ID #: SPI-CP-302
• Status: Completed
• Phase: N/A
• Start date: November 10, 2016
• Est. completion date: August 29, 2019

Study information

• Verified date: August 2020
• Source: Spirox, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: August 29, 2019
• Est. primary completion date: March 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nasal Obstruction

Intervention

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.

Locations

Country	Name	City	State
United States	ENT of Georgia	Atlanta	Georgia
United States	Alessi Institute For Facial Plastic Surgery	Beverly Hills	California
United States	Beverly Hills Aesthetic Surgical Institute	Beverly Hills	California
United States	ENT Assoc. of South Florida	Boca Raton	Florida
United States	The Center for Sinus, Allergy, & Sleep Wellness	Boynton Beach	Florida
United States	Chicago Nasal & Sinus Center	Chicago	Illinois
United States	Collin County ENT	Frisco	Texas
United States	Madison ENT & Facial Plastic Surgery	New York	New York
United States	Ogden Clinic	Ogden	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Spirox, Inc.	New Arch Consulting

Country where clinical trial is conducted

United States, 

References & Publications (2)

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/la — View Citation

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. Ep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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).	1, 3, 12, 18, and 24 months post procedure.
Secondary	Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS)	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.	1, 3, 6, 12, 18, and 24 months post procedure
Secondary	Subject Satisfaction Questionnaire	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.	6 months
Secondary	Procedure and Device-related Adverse Events	Number of participants who experience procedure- or device-related adverse events.	After 6 months and up to 12 months post procedure