Chronic Rhinosinusitis Trial, Completed NCT00939471 Sponsor: Integra LifeSciences Corporation Condition: Chronic Rhinosinusitis
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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 44 children (all in a single group who received the balloon sinus procedure). Of those, 33 completed the study and 11 did not finish. The trial was measuring two main things: whether any problems directly caused by the balloon device occurred over 12 months, and whether children's sinus symptom scores changed after the procedure. There was no comparison group — everyone in the study received the same treatment. The reported data shows that zero device-related problems were recorded over the 12-month follow-up period. For sinus symptoms, the trial used a questionnaire called the SN-5, which is scored between 1 and 7 — a lower score is meant to indicate fewer symptoms. The reported average reduction in score from before the procedure to 52 weeks afterwards was 2.00 points. On the secondary measures, the reported data shows that the balloon successfully reached and opened the targeted sinus openings in approximately 90.9% of cases. Around 68.3% of participants were reported to have used less sinus medication at their last recorded check-in. Zero additional procedures (such as irrigation or cleaning) were reported as needed after the initial treatment. The reported average number of days children missed school during the 12-month follow-up was 5.75 days. It is worth noting that this trial had no comparison group, so the numbers above describe what was recorded for this one group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

NCT00939471
Completed Not Applicable

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:

  • Children between the ages of 2 and 18 years old
  • Both boys and girls are eligible
  • Children who are scheduled to have a sinus-related surgical procedure (such as endoscopic sinus surgery, removal of the adenoids, or a sinus wash to collect a sample), as recommended by the doctor and agreed to by a parent or legal guardian
  • Children who have had long-lasting sinus problems, meaning either more than 3 months of symptoms OR 6 or more sinus infections per year, AND who have already tried 2 rounds of antibiotics without improvement, AND who have had a CT scan showing sinus problems

Who may not be able to join:

  • Children who have had significant previous surgery on the sinuses in the areas being studied
  • Children diagnosed with cystic fibrosis
  • Children who have extensive new bone growth in or around the sinuses (confirm with trial site)
  • Children who have tumors or blockages in the nose or sinuses
  • Children who have had a facial injury that has changed the shape of their sinuses in a way that makes them hard to access
  • Children who have a condition that affects how the tiny hair-like structures in their airways work (confirm with trial site)
  • Girls who are of childbearing age and are currently pregnant or breastfeeding

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

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Trial details

Status
Completed
Phase
Not Applicable
Sponsor
Integra LifeSciences Corporation
Registry
ClinicalTrials.gov
Start date
1 April 2007
Est. completion
1 July 2009

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months; Effectiveness: Change in Sinus Symptom Scores (SN-5); Effectiveness: Change in Sinus Symptom Scores (SNOT-20)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov