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 enrolled 71 people who were treated using the FinESS Sineus System Balloon Dilation procedure, which is a type of balloon-based sinus procedure. Of those 71 participants, 67 completed the study and 4 did not finish. The trial was measuring three things: whether any complications related to the device or procedure occurred, whether the treated sinus opening (the area where the sinuses drain) remained open three months after the procedure as seen on a CT scan, and whether participants' sinus-related symptoms changed over 12 months using a standard symptom questionnaire called the SNOT-20. The reported data shows that, out of all participants, 1 person experienced a complication considered to be related to the device or procedure. For the CT scan check at three months, the reported data shows that 106 sinus openings (across all treated participants) were recorded as remaining open — noting that some participants may have had more than one opening treated. Regarding the symptom questionnaire, the SNOT-20 uses a scale where lower numbers mean fewer problems; participants rated each item from 0 (no problem) to 5 (as bad as it can be). The reported data shows an average score change of −1.8 from the start of the study to 12 months later. The trial's own description notes that a reduction of at least 0.8 is considered both statistically significant (meaning unlikely to be due to chance) and clinically meaningful by the study's standards. It is worth noting that this trial had only one group — there was no separate comparison or control group — so all figures reflect only the people who received the balloon dilation procedure. 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 ↗ · Read the linked publication on PubMed (PMID 19419611) ↗
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 2 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 and have been diagnosed with long-term (chronic) sinusitis affecting the maxillary sinuses (cheek sinuses) or both the cheek sinuses and nearby ethmoid sinuses.
- You have had a CT scan taken after trying treatments such as antibiotics or nasal steroid sprays, and the scan shows either a narrowing of the sinus drainage passage with at least 2mm of swelling in the lining of the cheek sinus, or a visible fluid or air level inside the cheek sinus.
Who may not be able to join:
- You have long-term sinusitis in other sinus areas, such as the back ethmoid, sphenoid, or frontal (forehead) sinuses.
- You are unable to understand the study, or you have a history of not following medical advice.
- You are unwilling or unable to sign a consent form agreeing to participate.
- You are currently taking part in another medical research study for an unapproved treatment.
- You have a history of a cognitive or mental health condition that could make it difficult to take part in the study.
- You have previously had any sinus surgery or procedure, including balloon sinuplasty.
- You are pregnant.
- You have a severely deviated nasal septum (the wall dividing your nostrils) that is blocking the sinus drainage area.
- You have a condition where the tiny hairs in your airways do not work properly (primary ciliary dysfunction) (confirm with trial site).
- You have hemophilia (a blood clotting disorder).
- You are currently receiving or have received chemotherapy or radiation treatment to the head or neck area within the past 6 months.
- You have cystic fibrosis.
- You have a known condition called Samter's Triad, which involves sensitivity to aspirin, asthma, and nasal polyps together.
- You have known tumors or blockages in your nose or sinuses.
- You have a history of fractures to the middle of your face or jaw surgery (not including a broken nose).
- You have insulin-dependent diabetes.
- You are unable to stop taking blood-thinning medication (such as warfarin) until your blood clotting levels reach a safe range before the procedure.
- You are unable to stop taking anti-platelet medications (such as clopidogrel or aspirin) for at least 14 days before the procedure.
- You are unable to stop taking anti-inflammatory medications (such as ibuprofen) or herbal/homeopathic medications for at least 14 days before the procedure.
- You have nasal polyps that could interfere with the treatment.
- Your CT scan or physical examination shows signs of a fungal sinus infection.
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
Incidences of Device-related or Procedure-related Complications; Patency of the Treated Area as Verified by CT Scan; Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement
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.