CompletedNot Applicable

Propel Drug-Eluting Sinus Stent Family Open Cohort

Germany215 participantsStarted 2023-06-01

Plain-language summary

The purpose of this study is to confirm the long-term clinical safety and performance, acceptability of identified risks, and to detect emerging risks based on factual evidence for the PROPEL family of products when used according to labeling (in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery). Additionally, this study intends to collect data on use of corticosteroid-eluting implants in the European CRS population. Data collected will be used to ensure continued consistency between clinical data, the information materials supplied by the manufacturer, and the risk management documentation.

Who can participate

Age range18 Years

SexALL

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 or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements. * Patient has or is intended to receive or be treated with an eligible Medtronic product * Patient is consented within the enrollment window of the therapy received, as applicable Exclusion Criteria: * Patient who is, or is expected to be, inaccessible for follow-up * Participation is excluded by local law * Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results

What they're measuring

Long-term safety and efficacy of corticosteroid-eluting implants in patients with CRS undergoing Functional Endoscopic Sinus Surgery (FESS)

Timeframe: 6 months

Trial details

NCT IDNCT05925985

SponsorMedtronic

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-02-19

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