TerminatedNot Applicable

Steroid Delivery to the Frontal Sinus Opening With a Bioabsorbable Implant vs. a Bioabsorbable Nasal Dressing

Stopped: Study enrollment was too slow to complete the study in a reasonable time

United States9 participantsStarted 2017-08-25

Plain-language summary

The purpose of this study is to compare how two different post-surgical treatments that both deliver steroids to the frontal sinus opening affect your healing after frontal sinus surgery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 18 and older * Diagnosis of chronic rhinosinusitis with nasal polyps based on the American Academy of Otolaryngology-Head and Neck Surgery guidelines * Patient scheduled for bilateral endoscopic sinus surgery with evidence of bilateral frontal sinus disease based on Computed Tomography (Lund-Mackay score greater than or equal to 1) * At the time of surgery bilateral frontal sinusotomy of type Draf 2a or 2b was performed using the same technique on both sides * Bilateral endoscopic sinus surgery performed successfully without complication * Frontal sinus opening diameter greater than 4.0 mm achieved (4 mm olive tipped suction easily passed into frontal sinus) Exclusion Criteria: * Any patient who had frontal sinus surgery for tumor * Allergy to mometesone and/or triamcinolone * Frontal sinusotomy type Draf 1 or Draf 3 performed * One or both frontal sinus openings not amenable to implant placement * Patients with chronic oral steroid dependent conditions * Invasive fungal sinusitis * Immune deficiency

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 12 months

Trial details

NCT IDNCT03188822

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-28

Results submitted2021-11-04

View on ClinicalTrials.gov More Chronic Rhinosinusitis (Diagnosis) trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.