Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03358329) involved 50 people who received a device called the S8 Sinus Implant. Of those 50 participants, 46 completed the study, while 4 did not finish. The trial was measuring whether any serious unwanted events related to the implant occurred, and also tracking how participants rated their sinus-related symptoms and nasal blockage over time — specifically at 90 days and 180 days after the procedure. The reported data shows that for the primary measure — the number of participants who experienced a serious harmful event linked to the implant — the figure was zero out of 50 participants over the course of the year-long follow-up period. For the secondary measures, participants filled out a sinus symptom questionnaire (scored from 0 to 110, where higher numbers mean worse symptoms). The reported data shows an average change of approximately minus 14.9 points at 90 days and minus 15.4 points at 180 days from where participants started — with negative numbers meaning scores went down from the starting point. For nasal blockage, rated on a 0 to 3 scale, the reported average change was minus 0.6 at both 90 days and 180 days from the starting point, again with negative numbers indicating scores moved downward from baseline. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Chronic Rhinosinusitis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have agreed to participate by signing a consent form approved by an ethics review board
- You are 18 years of age or older
- You are willing and able to follow the study's requirements and schedule
- You have been diagnosed with chronic sinusitis (long-term sinus inflammation) with nasal polyps, confirmed using recognised medical guidelines
- You have previously had sinus surgery (specifically, a procedure that removed tissue from both sides of the ethmoid sinuses — the sinuses between your eyes) at least 90 days before the screening visit
- You have nasal polyps blocking both sides of your ethmoid sinuses at a level that requires treatment (a polyp score of 2 or higher on each side)
- You are able to use a mometasone furoate nasal spray (a steroid nasal spray) every day
- You are able to tolerate numbing medication applied to the inside of the nose
- Based on the doctor's assessment, the shape of your sinuses allows a small implant device to be placed in the nose on both sides during an in-office procedure
- If you are a woman who could become pregnant, you must not currently be pregnant or breastfeeding, and you must agree not to become pregnant during the study
- If you are a woman who could become pregnant, you must agree to use a reliable form of birth control throughout the study
Who may not be able to join:
- You have very extensive nasal polyps (graded 4 on at least one side)
- You have significant scar tissue or internal adhesions (sticking together of tissues) inside your sinuses, graded 3 or 4 (confirm with trial site)
- You have received steroid injections (such as Kenalog) in the 30 days before the start of the study procedure
- You have taken steroid tablets, or used steroid rinses, drops, or nasal nebulised steroids in the 14 days before the start of the study procedure
- You rely on steroid tablets long-term to manage a condition such as COPD or asthma
- You have a known allergy or bad reaction to corticosteroids or mometasone furoate (the medication used in the implant)
- You have used certain biological medicines (monoclonal antibodies such as Dupixent, Nucala, or Xolair) for asthma, allergies, or nasal polyps in the 30 days before the study procedure
- You would need to use those biological medicines during the study period
- There is a physical blockage in your nose that would prevent the implant device from being placed correctly
- You have a known history of HIV or certain immune system deficiencies
- You currently have an acute (sudden/short-term) sinus infection
- There is any sign of a serious fungal sinus infection
- You have a serious illness (such as cancer) that could affect your health or ability to complete the 12-month study
- You are currently taking part in another clinical trial
- You have had a spinal fluid leak or lasting vision problems as a result of previous sinus surgery
- You have a known weakness or gap in a thin bone wall near the eye socket (lamina papyracea) (confirm with trial site)
- You have active tuberculosis or an active viral illness such as eye herpes, chickenpox, or measles
- You have a known history of glaucoma, high eye pressure, or a certain type of eye lens clouding (posterior subcapsular cataract)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Number of Participants With Implant-Related Serious Adverse Events
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.