Using Navigation to Improve Accuracy of Maxillary Balloon Sinusotomy

Phase 2

Recruiting

• Conditions: Chronic Maxillary Rhinosinusitis

• Registration Number: NCT06567821
• Lead Sponsor: Cedars-Sinai Medical Center

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 confirmed diagnosis of chronic maxillary rhinosinusitis without nasal polyposis (CRSwNP) will undergo maxillary balloon sinusotomy. Block randomization will be performed to determine which side will receive balloon sinusotomy with navigation and which will have balloon sinusotomy using traditional anatomic landmarks. Participants will be followed for approximately 1 month post-procedure for a total study participation time of approximately 3 months.

Study Timeline

• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-08-21
• Study First Posted: 2024-08-23
• Study Start: 2024-09-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Success Rate	12 months	There is a 30% expected improvement of success, in favor of navigation over non-navigation balloon sinuplasty devices.

Trial Locations

Locations (1)

Cedars Sinai; 🇺🇸 Los Angeles, California, United States