Using Navigation to Improve Accuracy of Maxillary Balloon Sinusotomy
Cedars-Sinai Medical Center
50 participants
Sep 4, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria7
- 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
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Interventions
The 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.
Locations(1)
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NCT06567821