Phase 3 Chronic Rhinosinusitis Trial, Completed (NCT01253577)

Phase 3 Chronic Rhinosinusitis Trial, Completed NCT01253577 Sponsor: Intersect ENT Condition: Chronic Rhinosinusitis

Printed from Voxsanity (voxsanity.com.au) — NCT01253577 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

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 (NCT01253577) enrolled 105 participants, all of whom received a sinus stent implant. The trial was a single-group study where each participant received two implants — one coated with a drug on one side of their sinuses, and one without the drug coating on the other side. This design allowed a direct comparison between the two sides within the same person. The trial was measuring things like whether the sinuses needed further medical procedures after the operation, whether there were any notable changes in eye pressure (a safety measure sometimes monitored when certain medications are used near the sinuses), and whether polyp regrowth occurred. Of the 105 people who started, 102 completed the study. The reported data shows that 33.3% of sinuses on the drug-coated implant side required some form of follow-up intervention (such as further surgery to clear scar tissue or a course of steroid tablets), compared with 46.9% of sinuses on the non-coated implant side. For the eye pressure safety measure, the reported data shows that 0% of participants experienced a clinically significant rise in eye pressure (defined in the study as a rise of more than 10 mmHg on the drug-coated side but not the other side). Regarding polyp regrowth, 18.8% of sinuses on the drug-coated side developed significant polyps, compared with 34.1% of sinuses on the non-coated side. These figures are percentages of sinuses (not always of individual people), and the study was designed to compare the two sides rather than to compare against a separate group of participants who received no treatment at all. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 22550039) ↗

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.

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 have long-term sinus inflammation on both sides of your face (lasting at least 8 weeks in a row), confirmed by a CT scan
Your doctor has recommended and you have agreed to a type of sinus surgery called FESS (a procedure to open and clear blocked sinuses)
Your FESS surgery was completed successfully and without serious problems, and your sinuses are still suitable for having a small stent (a tiny device to keep the sinus open) placed inside
A CT scan taken within the last 6 months confirms your sinus condition
Your CT scan results show a minimum level of sinus disease based on a standard scoring method (called the Lund-Mackay score of 6 or more) (confirm with trial site)
Your CT scan shows that the small sinus cavities behind your eyes (ethmoid sinuses) are affected on both sides

Who may not be able to join:

You use insulin to manage your diabetes
You regularly take steroid tablets (by mouth) for an ongoing condition
You have glaucoma, high pressure in your eyes, or a specific type of eye condition called posterior subcapsular cataracts
You have had a surgical procedure where part of a bone structure inside your nose (the middle turbinate) was removed

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

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I found the following past clinical trial relevant to my condition, and wanted to raise it with you. It is no longer recruiting, but I wanted to ask whether similar active trials exist, or whether its results are relevant to my care:

Trial: NCT01253577

Sponsor: Intersect ENT

Phase: Phase 3

Status: Completed

Condition: Chronic Rhinosinusitis

More information: https://clinicaltrials.gov/study/NCT01253577

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You have long-term sinus inflammation on both sides of your face (lasting at least 8 weeks in a row), confirmed by a CT scan
Your doctor has recommended and you have agreed to a type of sinus surgery called FESS (a procedure to open and clear blocked sinuses)
Your FESS surgery was completed successfully and without serious problems, and your sinuses are still suitable for having a small stent (a tiny device to keep the sinus open) placed inside
A CT scan taken within the last 6 months confirms your sinus condition
Your CT scan results show a minimum level of sinus disease based on a standard scoring method (called the Lund-Mackay score of 6 or more) (confirm with trial site)
Your CT scan shows that the small sinus cavities behind your eyes (ethmoid sinuses) are affected on both sides

Who may not be able to join:

You use insulin to manage your diabetes
You regularly take steroid tablets (by mouth) for an ongoing condition
You have glaucoma, high pressure in your eyes, or a specific type of eye condition called posterior subcapsular cataracts
You have had a surgical procedure where part of a bone structure inside your nose (the middle turbinate) was removed

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Completed

Phase

Phase 3

Sponsor

Intersect ENT

Registry

ClinicalTrials.gov

Start date

1 December 2009

Est. completion

1 October 2010

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Percentage of Sinuses Requiring Post-operative Intervention; Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure

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