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

Not Applicable

Completed

• Conditions: Nasal Valve Collapse; Nasal Breathing
• Interventions: Device: Sham Procedure; Device: Latera Implant

• Registration Number: NCT03400787
• Lead Sponsor: Spirox, Inc.

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.

Study Timeline

• Study Start: 2017-11-28
• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-17
• Primary Completion: 2019-02-01
• Results First Submitted: 2019-11-25
• Results First Submitted QC: 2019-12-19
• Results First Posted: 2020-01-09
• Study Completion: 2020-12-23
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Latera Treatment Arm	Sham Procedure	Subjects in the active treatment arm will receive the Latera Implant using standard techniques. Follow up continues for 24 months post-implant.
Sham Control Arm	Latera Implant	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.

Primary Outcome Measures

Name	Time	Method
NOSE Responder Rate	3 months postprocedure.	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.

Secondary Outcome Measures

Name	Time	Method
Responder Rate	7 days, 30 days, and 6, 12, 18 and 24 months.	Responder Rate at 7 days, 30 days, and 6, 12, 18 and 24 months will be assessed

Trial Locations

Locations (11)

Michiana Sleep and ENT Solutions; 🇺🇸 South Bend, Indiana, United States

Texas Facial Plastics and ENT; 🇺🇸 San Antonio, Texas, United States

ENT of GA; 🇺🇸 Atlanta, Georgia, United States

Chicago Nasal and Sinus Center; 🇺🇸 Chicago, Illinois, United States

Sacramento ENT; 🇺🇸 Roseville, California, United States

Piedmont ENT; 🇺🇸 Winston-Salem, North Carolina, United States

Breathe Clear Institute; 🇺🇸 Torrance, California, United States

Albany ENT & Allergy; 🇺🇸 Albany, New York, United States

ENT Associates of Texas; 🇺🇸 McKinney, Texas, United States

Texas ENT Specialist; 🇺🇸 Houston, Texas, United States

Ogden Clinic; 🇺🇸 Ogden, Utah, United States