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Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant

NCT06163404 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-03-30

No results posted yet for this study

Summary

Pilot study of bioabsorbable implant and delivery device for correction of septal deviation.

Conditions

  • Nasal Septal Deviation
  • Nasal Airway Obstruction

Interventions

DEVICE

Implantation of Spirair Nasal Device using the Spirair delivery system.

The Spirair implant is designed to acutely correct cartilaginous septal deviation and maintain the cartilage in a corrected position for a duration sufficient to allow for cartilaginous remodeling.

Sponsors & Collaborators

  • Spirair, Inc

    lead INDUSTRY

Principal Investigators

  • Brandon McCutcheon, MD · Spirair, CMO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2027-03-31
Completion
2027-06-30
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 NCT06163404 on ClinicalTrials.gov