Propel Drug-Eluting Sinus Stent Family Open Cohort

Medtronic

Status

Active, not recruiting

Conditions

Chronic Rhinosinusitis (Diagnosis)

Treatments

Other: NA-Observational Registry

Study type

Observational

Funder types

Industry

Identifiers

NCT05925985

PSR Ear, Nose and Throat

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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