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 involved 50 people who had a device called the Sinexus Intranasal Splint placed inside their nasal sinuses. The trial was measuring how often the device could be successfully placed, and whether any serious reactions to the device occurred in the sinus tissue. Forty-five participants completed the study, while five did not finish. The reported data shows that out of the sinuses where placement was attempted, 90 were recorded as successful placements. For the main safety measure — tracking any serious adverse local tissue responses (meaning significant harmful reactions in the sinus tissue) — 6 sinuses had such a response recorded. For the secondary outcomes, the reported data shows that zero participants experienced a significant rise in eye pressure (intra-ocular pressure), which was one of the eye-related safety checks carried out. Separately, only 1 sinus was recorded as having a significant post-operative adhesion — meaning scar-like tissue joining structures inside the nose in a way considered clinically meaningful on the grading scale used in the study. It is worth noting that the data does not report the total number of sinuses attempted, so the full context for some of these numbers cannot be determined from the information provided. 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 have been diagnosed with chronic sinusitis (long-term sinus problems)
- Your doctor has recommended a type of sinus surgery called FESS (a minimally invasive procedure to clear the sinuses) and you have agreed to have it
- A CT scan (a detailed type of X-ray) taken within the last 6 months confirms your chronic sinusitis diagnosis
- Your CT scan shows that the disease is present in the ethmoid sinuses (small sinuses located between your eyes)
- Your planned surgery includes full removal of tissue in the ethmoid sinuses on one or both sides
Who may not be able to join:
- You have a condition where your immune system does not work properly (such as certain immune deficiency conditions)
- You rely on oral steroid tablets to manage COPD, asthma, or another condition
- You currently show signs of an active bacterial sinus infection
- You have been diagnosed with glaucoma or high pressure in your eyes
- There is evidence or suspicion that you have an invasive fungal sinus infection
- You have a disease or condition that may affect your survival or your ability to attend follow-up appointments
- You have a known allergy or bad reaction to corticosteroids (a type of medication)
- You have insulin-dependent diabetes (a type of diabetes managed with insulin injections)
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
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT); Device Placement Success Rate
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.