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

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

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.

Study Overview

• Status: Completed
• Conditions: Nasal Breathing; Nasal Valve Collapse
• Intervention / Treatment: Device: Latera Implant; Device: Sham 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.

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Roseville, California, United States, 95661
      • Sacramento ENT
    • Torrance, California, United States, 90503
      • Breathe Clear Institute
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • ENT of GA
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Chicago Nasal and Sinus Center
  • Indiana
    • South Bend, Indiana, United States, 46635
      • Michiana Sleep and ENT Solutions
  • New York
    • Albany, New York, United States, 12206
      • Albany ENT & Allergy
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Piedmont ENT
  • Texas
    • Houston, Texas, United States, 77094
      • Texas ENT Specialist
    • McKinney, Texas, United States, 78209
      • ENT Associates of Texas
    • San Antonio, Texas, United States, 78239
      • Texas Facial Plastics and ENT
  • Utah
    • Ogden, Utah, United States, 84403
      • Ogden Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Control Arm; Subjects in the Sham Control arm will undergo the same preoperative assessments as those in the Latera Treatment arm up to and including anesthesia for the implant, however, no implant will be placed. Crossover - Subjects will be unblinded after the 3-month assessment is complete. Eligible subjects in the Sham Control arm will be treated with the Latera Implant if they still meet all eligibility criteria. Follow up will continue to 24 months post-implant. Subjects who no longer meet the eligibility criteria will exit the study.	Device: Latera Implant; Treatment with implant
Experimental: Latera Treatment Arm; Subjects in the active treatment arm will receive the Latera Implant using standard techniques. Follow up continues for 24 months post-implant.	Device: Sham Procedure; Sham procedure where the Latera delivery device is inserted but no implant delivered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Spirox, Inc.
• Collaborators: New Arch Consulting
• Investigators: Principal Investigator: Pablo Stolovitzky, MD, ENT of Georgia; Principal Investigator: Douglas Sidle, MD, Northwestern Facial Plastic Surgery

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2017
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): December 23, 2020

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: nasal airway obstruction; sham-control; Polylactide absorbable implant
• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: CP 04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes