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 looked at a small dissolvable implant called the Propel Nova Sinus Implant, which is placed inside the sinus openings (the natural drainage passages of the sinuses) after sinus surgery. The trial was designed to test whether the implant could be placed successfully, and to track how the sinus openings looked over time in terms of blockage, scarring, and inflammation. Fifteen adults were enrolled, all in a single treatment group. Fourteen of the fifteen participants completed the full follow-up period to 90 days. The reported data shows that for the primary outcome — whether the implant was placed successfully in the sinus opening within two attempts — the success rate was reported as 100% for frontal sinuses and 95.2% for maxillary sinuses. For the secondary outcomes, the data reports several measurements taken at baseline (before or at the time of implant), at around 30 days, and at around 90 days. Regarding sinus opening patency (whether the opening remained unblocked), the reported figures across the two sinus types and three time points ranged from 33.3% to 100%. For moderate-to-severe adhesions or scarring (grades 2 and 3, meaning scar tissue partially or significantly blocking the sinus opening), the reported percentages ranged from 0% to 33.4% across the time points and sinus types. Inflammation scores (measured on a scale of 0 to 100, where higher means more inflammation) were reported as starting around 51–63 at baseline, and falling to around 14–28 by 90 days. A symptom questionnaire called the SNOT-22 (scored 0–110, where higher means more troublesome symptoms) was reported as starting at an average of 42.6, dropping to 21.5 at 30 days and 20.6 at 90 days. It is worth noting that this was a very small, single-group trial with no comparison group, and all figures are based on 14–15 participants. The reported data shows what was measured in this specific group of people; it does not tell us what would have happened without the implant. 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.
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 are 18 years of age or older.
- You are willing and able to follow the study's requirements and attend follow-up visits.
- You have been diagnosed with chronic sinusitis (long-term inflammation of the sinuses and nasal passages) confirmed by a CT scan, with symptoms lasting more than 8 weeks in a row.
- Your sinusitis affects at least two but no more than four specific sinuses (the frontal sinuses above your eyes and/or the maxillary sinuses in your cheekbones).
- Your doctor has recommended sinus surgery, either in a hospital operating room or a clinic setting.
- You have nasal polyps (small growths in the nose) that are small (grade 2 or lower), or you have larger polyps that can be removed during the surgery before the study device is placed.
- Your CT scan was taken within the last 6 months and confirms the diagnosis.
- Your CT scan shows a certain minimum level of sinus disease (a score of 6 or higher using a standard medical scoring system called Lund-Mackay).
- Your planned surgery includes specific techniques to open the affected sinuses to at least 5mm on both sides, using the same approach on both sides.
- If needed, a procedure to straighten the wall inside your nose (septoplasty) is allowed as part of the surgery.
- If you are a woman who could become pregnant, you must not currently be pregnant and must agree to use a reliable form of birth control for the duration of the study.
Who may not be able to join:
- You have severe nasal polyps (grade 3 or 4) that cannot be fully removed before the study device is placed.
- You have significant scarring or blockages inside your sinuses (grades 3 or 4) that cannot be cleared before the device is placed.
- You have a known immune system deficiency (such as certain antibody deficiencies or HIV).
- You are currently receiving chemotherapy or immunotherapy for any condition such as cancer.
- You rely on oral steroids (steroid tablets taken by mouth) to manage a condition such as asthma or COPD.
- You have a known allergy or bad reaction to corticosteroids or to the specific steroid used in this study (mometasone furoate).
- You currently have signs of an active bacterial sinus infection (such as sudden increase in thick discharge, fever, or facial pain).
- There is any concern that you may have a fungal sinus infection that is spreading into surrounding tissue (confirm with trial site).
- You have a health condition that may affect your survival or your ability to complete the 90-day follow-up period.
- You are currently taking part in another clinical trial.
- You have insulin-dependent diabetes (Type 1 diabetes or diabetes managed with insulin injections).
- You have previously had sinus surgery that resulted in a cerebrospinal fluid (CSF) leak (a leak of fluid surrounding the brain) or lasting vision problems.
- You have a known gap or weakness in the thin bone that separates your sinuses from your eye socket (confirm with trial site).
- You have an active viral illness such as tuberculosis, herpes simplex affecting the eye, chickenpox, or measles.
- A serious complication occurs during your surgery, such as major blood loss, a CSF leak, or injury to the bone near your eye socket.
- Your surgery is stopped or cancelled for any reason before completion.
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
Device Placement Success Rate
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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.