Cedars Sinai
Los Angeles, California, 90048, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06567821
Using Navigation to Improve Accuracy of Maxillary Balloon Sinusotomy
The purpose of the research is to examine the effectiveness of navigation in maxillary sinus balloon dilation for the treatment of chronic maxillary rhinosinusitis.
Recruiting
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Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
RELIEVA SPINPLUS® NAV Balloon Sinusplasty System
DeviceThe non-navigated device being used is the RELIEVA SPINPLUS® Balloon Sinusplasty System and the navigated device being used is the RELIEVA SPINPLUS® NAV Balloon Sinusplasty System. Both devices being used are standard devices that are currently FDA approved and used in practice for sinus dilation at Cedars-Sinai Medical Center.
Other names: RELIEVA SPINPLUS® Balloon Sinusplasty System
Primary outcomes
-
Success Rate
Time frame: 12 months
There is a 30% expected improvement of success, in favor of navigation over non-navigation balloon sinuplasty devices.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Cedars-Sinai Medical Center
Other
Registry information
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Aug 23, 2024
- Registry last updated
- Mar 11, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.