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Recruiting NCT06567821

Using Navigation to Improve Accuracy of Maxillary Balloon Sinusotomy

Phase II / Phase III Interventional Chronic Maxillary Rhinosinusitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RELIEVA SPINPLUS® NAV Balloon Sinusplasty System.
Who it may be relevant to
Registry conditions: Chronic Maxillary Rhinosinusitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Device 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.

Primary outcome measures

  • Success Rate [Time frame: 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Single blind
Primary purpose
Other

Study locations

United States · 1 center
  • Cedars Sinai — Los Angeles

Identifiers

NCT: NCT06567821 · STUDY00003097

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗