Latera RCT - Latera vs. Sham Control for Lateral Nasal Valve Collapse

Nasal Valve Collapse Clinical Trial

Official title:

Latera Randomized Controlled Trial (RCT) - Latera® Absorbable Nasal Implant vs. Sham Control for Lateral Nasal Valve Collapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400787
• Other study ID #: CP 04
• Status: Completed
• Phase: N/A
• Start date: November 28, 2017
• Est. completion date: December 23, 2020

Study information

• Verified date: January 2021
• Source: Spirox, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the LATERA RCT is to demonstrate the superiority of the Latera Implant to improve nasal breathing, compared with a Sham Control procedure.

Description:

To evaluate the Latera Absorbable Nasal Implant (Latera Implant) Implant versus Sham Control in subjects with nasal valve collapse due to or primarily due to insufficient cartilaginous support of the lateral nasal wall.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: December 23, 2020
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Subjects must meet the following criteria to be included in the study:

1. Adults aged 18 and above;

2. Understands and provides written informed consent;

3. Stated willingness to comply with all study procedures, post-treatment care and availability for the duration of the study follow up of 2 years;

4. In good general health as evidenced by medical history;

5. NOSE score =55;

6. Dynamic bi-lateral nasal wall insufficiency as confirmed by Positive Modified Cottle Maneuver;

7. Nasal and facial anatomy appropriate to receive the Latera Implant;

8. Documented failure of benefit after at least 4 weeks of conservative medical management, including, for example, antihistamines or nasal steroids, evidenced by lack of efficacy or tolerability.

Subjects meeting any one of the following criteria will be excluded for the study:

1. Unable to tolerate or not a candidate for procedures performed under local anesthesia;

2. Pathology other than lateral wall insufficiency (e.g. septal deviation, turbinate or adenoid hypertrophy, polyps, sinusitis, rhinitis) is the primary contributor to airway obstruction;

3. Requires or is anticipated to require any other concurrent nasal procedures (e.g. Functional Endoscopic Sinus Surgery (FESS), rhinoplasty, sinuplasty, septoplasty, or turbinate reduction) outside of the index procedure within 12 months after the index procedure;

4. FESS, sinuplasty, septoplasty, inferior turbinate reduction, or rhinoplasty within the past 6 months;

5. Any other rhinoplasty procedures are planned or planned usage of external dilators within 24 months after the index procedure;

6. Permanent nasal implant of any type (e.g. autologous, homologous, or synthetic graft) or dilator;

7. Presence of concomitant inflammatory or infectious conditions or unhealed wounds in the treatment area (e.g., vestibulitis, vasculitis, active acne),

8. Currently using chronic systemic steroids or recreational intra-nasal drugs;

9. Currently has cancerous or pre-cancerous nasal lesions, has had radiation in the treatment area, or is currently receiving chemotherapy;

10. History of a significant healing disorders including hypertrophic scarring, or keloid formation;

11. Poorly controlled diabetes mellitus;

12. Known or suspected allergy to PLA or other absorbable implant materials in the Latera Implant;

13. Severe obstructive sleep apnea (OSA) and cannot or is unwilling to refrain from continuous positive airway pressure (CPAP) for up to 2 weeks post-procedure based on expected healing needs and mask types, in agreement with the treating physician;

14. Female subjects, of child bearing potential, known or suspected to be pregnant or are lactating;

15. Any other presenting condition that, in the medical opinion of the investigator, would disqualify the subject from the study.

Related Conditions & MeSH terms

• Nasal Breathing
• Nasal Valve Collapse
• Shock

Intervention

Device:
• Latera Implant
Treatment with implant
• Sham Procedure
Sham procedure where the Latera delivery device is inserted but no implant delivered.

Locations

Country	Name	City	State
United States	Albany ENT & Allergy	Albany	New York
United States	ENT of GA	Atlanta	Georgia
United States	Chicago Nasal and Sinus Center	Chicago	Illinois
United States	Texas ENT Specialist	Houston	Texas
United States	ENT Associates of Texas	McKinney	Texas
United States	Ogden Clinic	Ogden	Utah
United States	Sacramento ENT	Roseville	California
United States	Texas Facial Plastics and ENT	San Antonio	Texas
United States	Michiana Sleep and ENT Solutions	South Bend	Indiana
United States	Breathe Clear Institute	Torrance	California
United States	Piedmont ENT	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Spirox, Inc.	New Arch Consulting

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stolovitzky P, Senior B, Ow RA, Mehendale N, Bikhazi N, Sidle DM. Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial. Int Forum Allergy Rhinol. 2019 Aug;9(8):850-856. doi: 10.1002/al — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NOSE Responder Rate	The primary endpoint of the study is the NOSE Responder Rate, assessed 3 months post-procedure in the per-protocol population of the Latera and Sham arms. The Nasal Obstruction Symptom Evaluation (NOSE) is a validated patient-reported outcome assessment of 5 questions relating to nasal obstruction (congestion, obstruction, trouble breathing through the nose, trouble sleeping, unable to breath through the nose during exercise/exertion. Each question is rated on a Likert scale of 0 (no problem) to 4 (severe problem). The sum of the scores is multiplied by 5 to result in a total score that ranges from 0 to 100. NOSE scores can also be categorized as mild (5-25), moderate (30-50), severe (55-75), and extreme (80-100). A NOSE responder is defined as a participant with at least 1 NOSE class improvement or at least 20% total NOSE score reduction.	3 months postprocedure.
Secondary	Responder Rate	Responder Rate at 7 days, 30 days, and 6, 12, 18 and 24 months will be assessed	7 days, 30 days, and 6, 12, 18 and 24 months.