Using Navigation to Improve Accuracy of Maxillary Balloon Sinusotomy
Status and phase
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Details and patient eligibility
About
The purpose of the research is to examine the effectiveness of navigation in maxillary sinus balloon dilation for the treatment of chronic maxillary rhinosinusitis.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Central trial contact
Shruti Shantharam
Data sourced from clinicaltrials.gov
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