Using Navigation to Improve Accuracy of Maxillary Balloon Sinusotomy

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT06567821
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Chronic Maxillary Rhinosinusitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • RELIEVA SPINPLUS® NAV Balloon Sinusplasty System — DEVICE
    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.

Study Details

The purpose of the research is to examine the effectiveness of navigation in maxillary sinus balloon dilation for the treatment of chronic maxillary rhinosinusitis.

Key Dates

Start date
Sep 4, 2024
Status verified
Mar 2026
Primary completion
Oct 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Primary Outcome Measure

Success Rate [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars SinaiLos AngelesCalifornia90048
Dennis M Tang, MD
[email protected]
310-423-1220
Dennis M Tang, MD (PRINCIPAL_INVESTIGATOR)

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Cedars Sinai· Los Angeles, CA