Clinical trial NCT03400787: Latera RCT - Latera vs. Sham Control for Lateral Nasal Valve Collapse
Official title: Latera Randomized Controlled Trial (RCT) - Latera® Absorbable Nasal Implant vs. Sham Control for Lateral Nasal Valve Collapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Valve Collapse
Nasal Breathing
Keywords: nasal airway obstruction
sham-control
Polylactide absorbable implant
Lead sponsor: Spirox, Inc.
Sponsor class: INDUSTRY
Collaborators: name: New Arch Consulting
First posted: 2018-01-17
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Sham procedure participants will be allowed to crossover to receive Latera implants after the 3-month assessment if they continue to meet eligibility criteria. Crossover participants will be followed through 24 months post implant. Sham participants who do not crossover will be exited after the 3-month assessment.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: NOSE Responder Rate
timeFrame: 3 months postprocedure.
Secondary outcomes:
measure: Responder Rate
timeFrame: 7 days, 30 days, and 6, 12, 18 and 24 months.
Other outcomes:
Locations:
city: Roseville
country: United States
facility: Sacramento ENT
state: California
city: Torrance
country: United States
facility: Breathe Clear Institute
state: California
city: Atlanta
country: United States
facility: ENT of GA
state: Georgia
city: Chicago
country: United States
facility: Chicago Nasal and Sinus Center
state: Illinois
city: South Bend
country: United States
facility: Michiana Sleep and ENT Solutions
state: Indiana
city: Albany
country: United States
facility: Albany ENT & Allergy
state: New York
city: Winston-Salem
country: United States
facility: Piedmont ENT
state: North Carolina
city: Houston
country: United States
facility: Texas ENT Specialist
state: Texas
city: McKinney
country: United States
facility: ENT Associates of Texas
state: Texas
city: San Antonio
country: United States
facility: Texas Facial Plastics and ENT
state: Texas
city: Ogden
country: United States
facility: Ogden Clinic
state: Utah
Study officials:
affiliation: ENT of Georgia
name: Pablo Stolovitzky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern Facial Plastic Surgery
name: Douglas Sidle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/alr.22362. Epub 2019 Jun 21.