Chronic Maxillary Rhinosinusitis
Conditions
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.
Interventions
DEVICERELIEVA SPINPLUS® NAV Balloon Sinusplasty System
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.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The procedure will be recorded for subsequent blinded review.
Intervention model description
This is a prospective randomized single blinded study. A block randomization will be performed to randomize each candidate to determine which side will receive a balloon sinusotomy without navigation and which side will receive balloon sinusotomy with the assistance of navigation. Each person has a set of sinuses on the right side and a set of sinuses on the left side. One side will be randomized to the balloon dilation with navigation while the other side will be performed with balloon dilation without navigation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate | 12 months | There is a 30% expected improvement of success, in favor of navigation over non-navigation balloon sinuplasty devices. |
Countries
United States
Contacts
CONTACTShruti Shantharam
Outcome results
None listed