Chronic Rhinosinusitis Trial, Completed NCT02278484 Sponsor: Entellus Medical, Inc. Condition: Chronic Rhinosinusitis
Back to Chronic Rhinosinusitis

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 50 participants, and all 50 completed the study — none dropped out. The trial involved children with sinus problems who underwent a procedure called balloon sinus dilation, where a small balloon is gently inflated inside the sinus passages. The study was measuring whether the balloon device could be successfully used to open the sinuses, whether any serious complications occurred, and how participants' sinus-related quality of life changed over time. The reported data shows that out of all the sinus dilation attempts made during the procedures, 157 were recorded as technically successful — meaning the device was delivered to the target sinus, inflated, deflated, and removed as intended. The reported data also shows that zero participants experienced a serious complication related to the device or procedure, and zero participants needed any additional or follow-up sinus surgery during the study period. For quality of life, caregivers completed a sinus symptom survey (called the SN-5) before and after the procedure, where scores range from 1 (best) to 7 (worst). The reported data shows an average change of −2.9 points, meaning scores moved in the direction of fewer reported symptoms on that scale. It is worth noting that this trial had only one group — everyone received the balloon sinus dilation procedure — so there was no comparison group receiving a different or no treatment. 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

NCT02278484
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:

  • You are between 2 and 21 years old
  • You have been diagnosed with Chronic Rhinosinusitis (a long-term condition where the sinuses are inflamed or blocked)
  • Your doctor has suggested you may be a suitable candidate for a procedure where a small balloon is used inside the nose to open up the sinuses

Who may not be able to join:

  • You have had sinus surgery in the past
  • You have recently had surgery on your nose, head, or neck
  • You have a fungal infection in your sinuses
  • You have severe asthma
  • You have cystic fibrosis
  • You have a condition that affects your immune system's ability to fight illness
  • You have differences in the structure of your skull or face (confirm with trial site)
  • You are currently pregnant

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.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Not Applicable
Sponsor
Entellus Medical, Inc.
Registry
ClinicalTrials.gov
Start date
1 September 2014
Est. completion
1 September 2015

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Technical Success: Sinuses Successfully Treated With Balloon Dilation; Complications

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