NCT06567821PHASE2, PHASE3RecruitingAccepts Healthy Volunteers

Using Navigation to Improve Accuracy of Maxillary Balloon Sinusotomy

Cedars-Sinai Medical Center

Start Date

9/4/2024

Completion Date

12/31/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

RELIEVA SPINPLUS® NAV Balloon Sinusplasty System

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Conditions

Chronic Maxillary Rhinosinusitis

Locations

Cedars Sinai

Los Angeles, California 90048

United States