Chronic Rhinosinusitis Trial, Completed NCT01525849 Sponsor: Entellus Medical, Inc. 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 enrolled 151 people with sinus problems — 76 assigned to a procedure called Balloon Sinus Dilation (BSD) and 75 assigned to a more traditional surgical approach called Functional Endoscopic Sinus Surgery (FESS). The trial was measuring two main things: how much participants' sinus symptoms changed over time (using a 20-question symptom survey called the SNOT-20, where a lower score means fewer or less severe symptoms), and how many follow-up clinic visits involving nasal cleaning (called "debridements") each person needed after their procedure. By the end of the study, 71 people in the BSD group and 59 in the FESS group had completed all follow-up. The reported data shows that both groups had similar reductions in their symptom survey scores. On average, BSD participants' SNOT-20 scores dropped by 1.59 points from their starting score, while FESS participants' scores dropped by 1.60 points — essentially the same change in both groups. When it came to post-procedure clinic cleaning visits, the reported data shows BSD participants averaged 0.23 visits per person, compared to 1.03 visits per person in the FESS group. For the secondary measures, the reported data shows that 1 participant in each group needed a repeat sinus procedure. The number of participants who experienced a serious adverse event (an unexpected harmful event considered related to the device or procedure) was reported as zero in both groups. The reported data also shows that BSD participants returned to normal activities in an average of 1.7 days, compared to 5.0 days for FESS participants. 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

NCT01525849
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 18 years of age or older
  • You have a condition affecting your maxillary sinus (the large sinus cavity located behind your cheekbones)
  • You have chronic sinusitis (long-lasting inflammation or infection of the sinuses)

Who may not be able to join:

  • You have a fungal infection or fungal-related disease
  • You have Samter's triad, which is a combination of asthma, nasal polyps, and sensitivity to aspirin (confirm with trial site)
  • You have hemophilia, a condition where your blood does not clot properly
  • You have had sinus surgery in the past

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
Entellus Medical, Inc.
Registry
ClinicalTrials.gov
Start date
1 December 2011
Est. completion
1 February 2014

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Sinus Symptom Improvement; Debridements

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