Chronic Rhinosinusitis Trial, Completed NCT02284347 Sponsor: Medtronic Surgical Technologies 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 (NCT02284347) involved 51 people who took part, with 48 completing the study and 3 not completing it. The trial tested a medical device called the NuVent™, which is used during sinus procedures. The study was measuring two main things: how well the device could be guided to the right spot inside the sinuses and how easily it could open up the sinus passages, as well as tracking any unwanted events that might be linked to the device. The reported data shows that across the participants, 121 sinuses were successfully navigated to the desired treatment location and had the sinus opening dilated as intended. For the primary safety measurement — which looked at any unwanted events directly linked to the device, or where the cause could not be ruled out — the reported number was zero. Separately, a secondary measurement tracked the broader rate of any unwanted events among participants (regardless of cause); the reported data shows that 18% of participants experienced at least one such event. No further breakdown of those events was provided in the submitted results. 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

NCT02284347
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 long-term sinus problems (chronic rhinosinusitis) that have not improved with medication or previous sinus surgery.
  • You are scheduled to have surgery on at least one of certain sinus openings (the frontal, sphenoid, or maxillary sinuses).
  • You have scar tissue, inflamed tissue, or tissue that has been changed by previous surgery, where a specific image-guided balloon tool may be usable, according to the doctor running the trial.
  • You are willing and able to follow all the requirements of the study.

Who may not be able to join:

  • You are pregnant or breastfeeding.
  • The doctor running the trial does not consider you healthy enough to safely have sinus surgery through the nose (endoscopic sinus surgery).
  • You have a tumor in or around your nose or sinuses.
  • You are currently taking part in another clinical study involving a medical device, biologic, or drug and have not yet completed the main part of that study, or your involvement could interfere with this trial's results.
  • You are not able to give your own consent to take part in this research.

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
Medtronic Surgical Technologies
Registry
ClinicalTrials.gov
Start date
1 December 2014
Est. completion
1 May 2015

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium; Device-related Adverse Event Point Estimate

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