Chronic Rhinosinusitis Trial, By Invitation NCT07286201 Sponsor: Polyganics BV Condition: Chronic Rhinosinusitis
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Chronic Rhinosinusitis Trial, By Invitation

NCT07286201
By Invitation 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 old or older
  • You are scheduled to have sinus surgery on both sides of your nose (called endoscopic sinus surgery) for a chronic sinus condition, with or without nasal polyps, and your surgeon plans to fully clear out specific sinus passages on both sides at minimum
  • You are willing and able to give your consent to participate
  • You are willing and able to follow the requirements of the study
  • Your pre-surgery CT scan shows a certain level of sinus blockage on both sides (a score of at least 3 per nostril on a standard sinus scoring scale — confirm with trial site)
  • The difference in sinus blockage between your left and right side is not too large (confirm with trial site)
  • If you are someone who could become pregnant, you are not currently pregnant and agree not to become pregnant during the study

Who may not be able to join:

  • You have a history of frequent nosebleeds, or you had a serious nosebleed that needed medical treatment in the past 3 months
  • You have a whole-body (systemic) condition known to affect the nose, such as Wegener's granulomatosis, sarcoidosis, or certain other inflammatory diseases
  • You have a blood clotting disorder or take medication that increases your risk of bleeding (except low-dose aspirin)
  • You have a known or suspected allergy to any materials used in the study device
  • You have hemophilia (a condition where blood does not clot properly)
  • You have diabetes that requires insulin
  • You depend on steroid tablets (taken by mouth) to manage a health condition
  • You have glaucoma, high pressure in your eyes, or a certain type of eye lens problem (posterior subcapsular cataracts)
  • You have previously been diagnosed with Samter's Triad, also known as Aspirin-Exacerbated Respiratory Disease (AERD)
  • You need to use nasal ointments or creams at the time the study device is placed
  • You have a neurological, medical, psychiatric condition, or personal situation that could increase your risk, affect your ability to take part, or make the study results harder to interpret (confirm with trial site)
  • You are planning to have any ear, nose, or throat procedure within the 90 days after your surgery
  • You are currently taking part in another clinical study, or have done so within 30 days before this study starts through to 90 days after your surgery
  • You have used any biologic medications (a type of specialist drug) within 90 days before your surgery and up to 25 days after
  • You have used any form of corticosteroid (steroid) medication within 2 weeks before your surgery

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

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Trial details

Status
By Invitation
Phase
Not Applicable
Sponsor
Polyganics BV
Registry
ClinicalTrials.gov
Start date
19 March 2026
Est. completion
1 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Rate of Serious Adverse Events; Endoscopic Assessment

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