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NCT03400787 · ClinicalTrials.gov registry record · NA
Latera RCT - Latera vs. Sham Control for Lateral Nasal Valve Collapse
A NA study of Nasal Valve Collapse and Nasal Breathing, sponsored by Spirox.
- Completed
- Registry status
- NA
- Development phase
- 137
- Enrollment target
- 11
- Study locations
NCT03400787: Completed NA study of Nasal Valve Collapse and Nasal Breathing, sponsored by Spirox.
NCT03400787 is a NA study of Nasal Valve Collapse and Nasal Breathing that has completed, run by Spirox. The registered enrollment target is 137 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03400787, a NA study of Nasal Valve Collapse and Nasal Breathing, has completed, sponsored by Spirox.
- COMPLETED
- Registry status
- NA
- Development phase
- 137 participants
- Enrollment target
- 11
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE Sham Procedure
- DEVICE Latera Implant
Study Locations (11)
Texas
- Texas ENT Specialist - Houston
- ENT Associates of Texas - McKinney
- Texas Facial Plastics and ENT - San Antonio
California
- Sacramento ENT - Roseville
- Breathe Clear Institute - Torrance
Georgia
- ENT of GA - Atlanta
Illinois
- Chicago Nasal and Sinus Center - Chicago
Indiana
- Michiana Sleep and ENT Solutions - South Bend
New York
- Albany ENT & Allergy - Albany
North Carolina
- Piedmont ENT - Winston-Salem
Utah
- Ogden Clinic - Ogden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2017-11-28 |
| Est. Completion | 2020-12-23 |
| Phase | NA |
What the finished NCT03400787 record still lists
NCT03400787 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Nasal Valve Collapse appearing as the primary indexed condition, and to 2 interventions - of which Sham Procedure is the first listed.
NCT03400787 lists 11 locations in 8 states (Texas, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT03400787 about?
NCT03400787 is a clinical study titled "Latera RCT - Latera 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.
What is the current status of trial NCT03400787?
This trial is currently completed. It is a NA study. The enrollment target is 137 participants. The study started on 2017-11-28. Estimated completion is 2020-12-23.
What conditions does trial NCT03400787 study?
This clinical trial studies the following conditions: Nasal Valve Collapse, Nasal Breathing.
What interventions are being tested in trial NCT03400787?
The interventions under investigation include: Sham Procedure (DEVICE), Latera Implant (DEVICE).
Who is sponsoring clinical trial NCT03400787?
This trial is sponsored by Spirox, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03400787 being conducted?
This trial has 11 study locations across California, Georgia, Illinois, Indiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03400787's enrollment target sits among peer trials
137 722nd of 2000 higher than 1,279 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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