Efficacy of ArchSinus, NasoPore & Propel to Prevent Post-Surgical MT Lateralization and Improve S… (NCT05156801) | Clinical Trial Compass
UnknownNot Applicable
Efficacy of ArchSinus, NasoPore & Propel to Prevent Post-Surgical MT Lateralization and Improve Symptomatic Outcomes
50 participantsStarted 2022-03
Plain-language summary
This is a multi-center, randomized, single-blinded comparative 3-arm clinical study. This clinical study is designed to compare the efficacy of the ArchSinus stent to the Propel stent (Intersect ENT), and to NasoPore (Stryker) in preventing post-FESS middle turbinate lateralization 3 weeks, 6 weeks, 3 months and 12 months post FESS.
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:
* Diagnosis of chronic rhinosinusitis defined as symptomatic inflammation of the sinuses of at least 12 consecutive weeks duration despite medical management
* CT scan examination with a minimum Zinreich score of 5 prior to study entry
* Less than 2-point Zinreich score difference between two sides
* Primary FESS including bilateral total ethmoidectomy; symmetrical uncinate process reduction
Exclusion Criteria:
* Inferior turbinectomy, reduction or outfracture
* Polyp grade ˃ 4 bilaterally on Lildholdt's scale (1-3)
* Concha bullosa
* Severe nasal septal deviation at the level of OMC
* Sinonasal tumors
* FESS including asymmetrical resection of the middle turbinate
* Known allergy to nickel
* Known polyurethane induced dermatitis
* Oral steroid-dependent condition
* Momometasone furoate intolerance
* Known hypersensitivity to lactide, glycolide or caprolactone copolymers.
* Glaucoma or cataract
* History of immune deficiency
* Cystic fibrosis
* Pregnant or lactating female
* Acute sinus inflammation
* Coagulation disorders
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
1
Middle turbinate lateralization 12 week post FESS (based CT scan)