Improving maxillary sinus surgery accuracy with navigation technology
Using Navigation to Improve Accuracy of Maxillary Balloon Sinusotomy
This study tests if using navigation technology during sinus surgery helps adults with chronic sinus issues feel better compared to traditional surgery methods.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06567821 on ClinicalTrials.gov |
What this trial studies
This research examines the effectiveness of using navigation technology during maxillary balloon sinus dilation for patients with chronic maxillary rhinosinusitis. Adult participants aged 18 and over, who have not responded to medical therapy and do not have nasal polyps, will be randomly assigned to receive either navigated or traditional balloon sinusotomy. The study will follow participants for about one month post-procedure to assess outcomes over a total participation time of approximately three months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic maxillary rhinosinusitis without nasal polyps who have failed medical therapy.
Not a fit: Patients with a history of previous sinus surgery, presence of nasal polyps, or other significant sinonasal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced complications for patients with chronic maxillary rhinosinusitis.
How similar studies have performed: Other studies have shown promise in using navigation technology for sinus surgeries, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California
- Cedars Sinai — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Shruti Shantharam
- Email: Shruti.Shantharam@csmns.org
- Phone: 5627873255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.