Using Navigation to Improve Accuracy of Maxillary Balloon Sinusotomy

Last updated: February 26, 2025
Sponsor: Cedars-Sinai Medical Center
Overall Status: Active - Recruiting

Phase

2/3

Condition

Nasal Obstruction

Sinus Infections

Rhinitis, Allergic, Perennial

Treatment

RELIEVA SPINPLUS® NAV Balloon Sinusplasty System

Clinical Study ID

NCT06567821
STUDY00003097
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults 18 years of age or older

  • Candidate for primary endoscopic sinus surgery (ESS) for chronic maxillaryrhinosinusitis without nasal polyposis (CRSwNP)

  • Failed medical (non-surgical) therapy

Exclusion

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 patientfrom participating in the study

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: RELIEVA SPINPLUS® NAV Balloon Sinusplasty System
Phase: 2/3
Study Start date:
September 04, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Cedars Sinai

    Los Angeles, California 90048
    United States

    Active - Recruiting

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