Chronic SinusitisPhase 2S8PKNCT01894503
Safety and Performance of the Steroid-Releasing S8 Sinus Implant
A Phase 2 study testing S8 Sinus Implant (mometasone furoate, 1350 mcg) in people with Chronic Sinusitis, run by Intersect ENT at 1 site in United States.
Trial summary
The purpose of this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- S8 Sinus Implant (mometasone furoate, 1350 mcg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Oct 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Diagnosis of chronic sinusitis
- Prior bilateral total ethmoidectomy
- Recurrent sinus obstruction due to polyps grade 2 or higher
Who cannot join
- Required use of mometasone furoate within 2 weeks prior to implant procedure
- Significant scarring or adhesions of the sinus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Evaluation of the Safety and Performance of the Steroid-Releasing S8 Sinus Implant When Used in Post-Sinus Surgery Patients With Recurrent Sinus Polyps
The purpose of this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.
Read the detailed description
The S8 PK study was a single-center, open label study treating 5 adult (18 years or older) patients diagnosed with chronic sinusitis, who had undergone prior bilateral total ethmoidectomy and later presented with recurrent nasal obstruction/congestion symptoms and bilateral ethmoid polyposis. The S8 PK study assessed the safety, implant delivery to the ethmoid sinus, and systemic exposure to mometasone furoate (MF) by measuring plasma MF and cortisol concentrations through 30 days post-procedure.
- Conditions
- Chronic Sinusitis
- Being tested
- S8 Sinus Implant (mometasone furoate, 1350 mcg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S8 Sinus Implant (mometasone furoate, 1350 mcg)Drug
Also called SINUVA (mometasone furoate) sinus implant
Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days
| Study group | Role | What they receive |
|---|---|---|
| S8 Sinus Implant | Experimental | Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses Receives: Drug: S8 Sinus Implant (mometasone furoate, 1350 mcg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Sinuses With Successful Implant Delivery
Defined as successful access and deployment of the S8 Sinus Implant to the target ethmoid sinus at the end of the baseline procedure
Measured: End of baseline procedure
Secondary outcomes (1)
Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ
Concentration of mometasone furoate was determined in blood samples collected at baseline, Days 3, 7, 14, 21 and 30 using a validated method with the lowest level of quantification (LLOQ) of 30 pg/ml.
Measured: Days 3, 7, 14, 21 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intersect ENT
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randall Ow, MD, Principal investigator, Sacramento ENT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894503
- Sponsor's protocol ID
- P500-0513
- Acronym
- S8PK
- Status last verified
- Mar 2017
- First submitted
- 3 Jul 2013
- Last updated
- 18 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: No plan
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the Safety and Performance of the Steroid-Releasing S8 Sinus Implant When Used in Post-Sinus Surgery Patients With Recurrent Sinus Polyps
- ClinicalTrials.gov ID
- NCT01894503
- Acronym / sponsor ID
- S8PK / P500-0513
- Conditions
- Chronic Sinusitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Intersect ENTIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Posted 25 Jun 2018
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 this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.
Detailed description
The S8 PK study was a single-center, open label study treating 5 adult (18 years or older) patients diagnosed with chronic sinusitis, who had undergone prior bilateral total ethmoidectomy and later presented with recurrent nasal obstruction/congestion symptoms and bilateral ethmoid polyposis. The S8 PK study assessed the safety, implant delivery to the ethmoid sinus, and systemic exposure to mometasone furoate (MF) by measuring plasma MF and cortisol concentrations through 30 days post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
| Arm | Type | Receives |
|---|---|---|
| S8 Sinus Implant | Experimental | Drug: S8 Sinus Implant (mometasone furoate, 1350 mcg)Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Diagnosis of chronic sinusitis
- Prior bilateral total ethmoidectomy
- Recurrent sinus obstruction due to polyps grade 2 or higher
Key exclusion criteria (2 listed)
- Required use of mometasone furoate within 2 weeks prior to implant procedure
- Significant scarring or adhesions of the sinus
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 |
|---|---|---|
| S8 Sinus Implant (mometasone furoate, 1350 mcg)Also: SINUVA (mometasone furoate) sinus implantBioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days | Drug | S8 Sinus Implant |
Primary outcome
Number of Sinuses With Successful Implant Delivery
Time frame: End of baseline procedure
Defined as successful access and deployment of the S8 Sinus Implant to the target ethmoid sinus at the end of the baseline procedure
1 secondary outcome
Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ
Time frame: Days 3, 7, 14, 21 and 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plan
Related trials for Chronic Sinusitis
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
Not yet recruiting
Effect of Probiotic Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
Sinusitis Chronic, Postoperative Care
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. This study is not recruiting at the moment.
Randall Ow, MD principal investigator
Sacramento ENT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S8 Sinus Implant (mometasone furoate, 1350 mcg) in people with Chronic Sinusitis, run by Intersect ENT 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 18 Jul 2018. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Sinuses With Successful Implant Delivery (time frame: End of baseline procedure). 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 18 Jul 2018.