Using Navigation to Improve Accuracy of Maxillary Balloon... | NCT06567821

Studies
Using Navigation to Improve Accuracy of Maxillary Balloon Sinusotomy

NCT06567821

Sponsor

Cedars-Sinai Medical Center

Status

Recruiting

Last Update Posted

Mar 11, 2026Actual

Enrollment

50Estimated

Phase

Phase 2Phase 3

Conditions

Chronic Maxillary Rhinosinusitis

Interventions

RELIEVA SPINPLUS® NAV Balloon Sinusplasty System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 4, 2024Actual

Primary Completion Date

Oct 1, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jul 15, 2024

First Submission Date that Met QC Criteria

Aug 21, 2024

First Posted Date

Aug 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2026

Last Update Posted Date

Mar 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.		RELIEVA SPINPLUS® Balloon Sinusplasty System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success Rate	There is a 30% expected improvement of success, in favor of navigation over non-navigation balloon sinuplasty devices.	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shruti Shantharam	Contact	5627873255		Shruti.Shantharam@csmns.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cedars Sinai	Recruiting	Los Angeles	California	90048	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Model Description

This is a prospective randomized single blinded study. A block randomization will be performed to randomize each candidate to determine which side will receive a balloon sinusotomy without navigation and which side will receive balloon sinusotomy with the assistance of navigation. Each person has a set of sinuses on the right side and a set of sinuses on the left side. One side will be randomized to the balloon dilation with navigation while the other side will be performed with balloon dilation without navigation.