Chronic Maxillary RhinosinusitisPhase 2/3NCT06567821
Using Navigation to Improve Accuracy of Maxillary Balloon Sinusotomy
A Phase 2/3 study testing RELIEVA SPINPLUS® NAV Balloon Sinusplasty System in people with Chronic Maxillary Rhinosinusitis, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Maxillary Rhinosinusitis
- What is being tested?
- RELIEVA SPINPLUS® NAV Balloon Sinusplasty System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to 31 Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars Sinai
Los Angeles, California, 90048
Dennis M Tang, MD, 310-423-1220, dennis.tang2@cshs.org
Dennis M Tang, MD
About this study
The purpose of the research is to examine the effectiveness of navigation in maxillary sinus balloon dilation for the treatment of chronic maxillary rhinosinusitis.
Read the 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.
- Conditions
- Chronic Maxillary Rhinosinusitis
- Being tested
- RELIEVA SPINPLUS® NAV Balloon Sinusplasty System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RELIEVA SPINPLUS® NAV Balloon Sinusplasty SystemDevice
Also called RELIEVA SPINPLUS® 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate
There is a 30% expected improvement of success, in favor of navigation over non-navigation balloon sinuplasty devices.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start4 Sep 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Maxillary RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Tang, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567821
- Sponsor's protocol ID
- STUDY00003097
- Status last verified
- Mar 2026
- First submitted
- 15 Jul 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Navigation to Improve Accuracy of Maxillary Balloon Sinusotomy
- ClinicalTrials.gov ID
- NCT06567821
- Acronym / sponsor ID
- STUDY00003097
- Conditions
- Chronic Maxillary Rhinosinusitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- 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.
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- History of previous sinus surgery
- Presence of nasal polyps
- Extensive sinonasal osteogeneis
- Cystic fibrosis
- Presence of sinonasal tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RELIEVA SPINPLUS® NAV Balloon Sinusplasty SystemAlso: RELIEVA SPINPLUS® Balloon Sinusplasty SystemThe 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. | Device | – |
Primary outcome
Success Rate
Time frame: 12 months
There is a 30% expected improvement of success, in favor of navigation over non-navigation balloon sinuplasty devices.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Maxillary Rhinosinusitis
Recruiting
Balloon Sinuplasty Efficiency in Maxillary Rhinosinusitis.
Maxillary Sinusitis, Sinusitis, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing RELIEVA SPINPLUS® NAV Balloon Sinusplasty System in people with Chronic Maxillary Rhinosinusitis, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shruti Shantharam (5627873255, Shruti.Shantharam@csmns.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.