Using Navigation to Improve Accuracy of Maxillary Balloon Sinusotomy
NCT ID: NCT06567821
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
50 participants
INTERVENTIONAL
2024-09-04
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
SINGLE
Interventions
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RELIEVA 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Candidate for primary endoscopic sinus surgery (ESS) for chronic maxillary rhinosinusitis without nasal polyposis (CRSwNP)
* Failed medical (non-surgical) therapy
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Dennis Tang
Physician
Locations
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Cedars Sinai
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00003097
Identifier Type: -
Identifier Source: org_study_id
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