Status:

RECRUITING

Using Navigation to Improve Accuracy of Maxillary Balloon Sinusotomy

Lead Sponsor:

Cedars-Sinai Medical Center

Conditions:

Chronic Maxillary Rhinosinusitis

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

Brief Summary

The purpose of the research is to examine the effectiveness of navigation in maxillary sinus balloon dilation for the treatment of chronic maxillary rhinosinusitis.

Detailed Description

The purpose of the research is to examine the effectiveness of navigation in maxillary sinus balloon dilation for the treatment of chronic maxillary rhinosinusitis. Adult patients (18 and over) with a...

Eligibility Criteria

Inclusion

  • Adults 18 years of age or older
  • Candidate for primary endoscopic sinus surgery (ESS) for chronic maxillary rhinosinusitis without nasal polyposis (CRSwNP)
  • Failed medical (non-surgical) therapy

Exclusion

  • History of previous sinus surgery
  • Presence of nasal polyps
  • Extensive sinonasal osteogeneis
  • Cystic fibrosis
  • Presence of sinonasal tumors
  • Any records flagged "break the glass" or "research opt out."
  • Any additional finding which in the opinion of the investigator precludes patient from participating in the study

Key Trial Info

Start Date :

September 4 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT06567821

Start Date

September 4 2024

End Date

December 31 2025

Last Update

February 28 2025

Active Locations (1)

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1

Cedars Sinai

Los Angeles, California, United States, 90048