In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia (NCT02880514) | Clinical Trial Compass
CompletedNot Applicable
In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia
United States50 participantsStarted 2016-08
Plain-language summary
A randomized controlled trial
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
* Patient has provided written informed consent using a form approved by the reviewing IRB.
* Patient is 18 years of age or older.
* Patient is willing and able to comply with protocol requirements.
* Patient has CRS defined as sinonasal inflammation persisting for more than 12 weeks and complains of at least 2 of the 4 following symptoms: nasal blockage/obstruction/congestion, nasal blockage/obstruction/congestion, nasal discharge (anterior/posterior), facial pain/pressure, reduction/loss of smell
* CRS diagnosis confirmed by CT scan within 3 months prior to enrollment
* Bilateral frontal sinusitis confirmed by Lund-Mackay score of ≥1 on each side
* Post-endoscopic sinus surgery, patient has bilateral obstruction of the frontal sinus ostia by scarring and/or polypoid edema.
* Patient is a candidate for an in-office balloon dilation procedure.
* In the opinion of the investigator, treatment with the Propel Mini Sinus Implant as an adjunct to balloon sinus dilation is technically feasible and clinically indicated in the frontal sinus ostia.
Exclusion Criteria:
* Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus of grade 3 or 4 unless reduced prior to randomization in the study.
* Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or other conditions.
* Known history of allergy or intolerance to corticosteroids or mometasone furoate.
* Clinical evidence of acute bacterial sinusitis or invasive…
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.