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

NCT03400787 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2021-02-09

Study results available
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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.

Conditions

  • Nasal Valve Collapse
  • Nasal Breathing

Interventions

DEVICE

Latera Implant

Treatment with implant

DEVICE

Sham Procedure

Sham procedure where the Latera delivery device is inserted but no implant delivered.

Sponsors & Collaborators

  • New Arch Consulting

    collaborator INDUSTRY

  • Spirox, Inc.

    lead INDUSTRY

Principal Investigators

  • Pablo Stolovitzky, MD · ENT of Georgia

  • Douglas Sidle, MD · Northwestern Facial Plastic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-28
Primary Completion
2019-02-01
Completion
2020-12-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03400787 on ClinicalTrials.gov