Recruiting
Phase 2
Phase 3

Navigation

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT06567821

Conditions

Chronic Maxillary Rhinosinusitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

RELIEVA SPINPLUS® NAV Balloon Sinusplasty System

Study Details

Brief 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.

Conditions

Chronic Maxillary Rhinosinusitis

Study ID

NCT06567821

Start date

Sep 4, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Interventions

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 measure

  • Success Rate [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Shruti Shantharam

5627873255Shruti.Shantharam@csmns.org

Locations

Cedars Sinai

Recruiting

Los Angeles, California, United States, 90048

Contacts

Dennis M Tang, MD

310-423-1220dennis.tang2@cshs.org

Principal Investigator:

Dennis M Tang, MD

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-03-11.