Chronic Rhinosinusitis Trial, Terminated NCT03188822 Sponsor: University of Rochester 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 (NCT03188822) enrolled 9 participants, all of whom received a bioabsorbable (dissolving) steroid-releasing sinus implant. The trial was comparing two different dissolving devices placed in the sinuses after surgery — a steroid-releasing sinus stent on one side and a steroid-soaked nasal dressing on the other side — looking at how the sinus opening appeared afterwards. Only 2 of the 9 participants completed the trial, and 7 did not complete it. Because so few participants finished, the reported numbers are based on a very small group. The reported data shows that for the main outcome — where an independent sinus specialist rated whether the stent side looked better, worse, or the same as the nasal dressing side — 0 participants were rated as worse, 1 was rated the same, and 1 was rated as better. For the secondary outcomes, scarring and swelling in the sinus opening were rated on a scale of 0 to 4 (where higher numbers mean a worse appearance). The reported data shows a range of scores across participants for both the left and right sides, with individual scores varying from 0 to 3 for scarring and 0 to 3 for swelling. For the size of the sinus opening (whether it measured 4 mm or more), the reported data shows results split across categories, though specific labels for each category were not included in the submitted data. It is important to note that with only 2 participants completing the trial, the reported numbers represent a very small and incomplete dataset, and the data was not reported for all participants across every measure. 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, Terminated

NCT03188822
Terminated 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 been diagnosed with chronic sinusitis (long-term sinus inflammation) with nasal polyps, confirmed using standard medical guidelines
  • You are scheduled for sinus surgery on both sides of your nose, and a CT scan has shown disease in both of your frontal sinuses (the sinuses located in your forehead)
  • During your surgery, a specific type of frontal sinus procedure (called Draf 2a or 2b) was performed the same way on both sides
  • Your sinus surgery on both sides was completed successfully without any complications
  • The opening created in your frontal sinus during surgery is large enough (wider than 4mm) to allow proper treatment

Who may not be able to join:

  • You had frontal sinus surgery because of a tumor
  • You are allergic to the medications mometasone or triamcinolone (types of steroids)
  • A different type of frontal sinus procedure (called Draf 1 or Draf 3) was performed during your surgery
  • One or both of your frontal sinus openings are not suitable for placing a small implant (confirm with trial site)
  • You have a long-term condition that requires you to take steroid tablets regularly by mouth
  • You have an aggressive fungal sinus infection
  • You have a condition that weakens your immune system

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
Terminated
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
25 August 2017
Est. completion
28 September 2021

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing

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