Propel Drug-Eluting Sinus Stent Family Open Cohort

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

215 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Rhinosinusitis (Diagnosis)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Propel

Patients implanted with Propel model implants

NA-Observational Registry

Intervention Type OTHER

NA Observational Registry

Propel Mini

Patients implanted with Propel Mini model implants

NA-Observational Registry

Intervention Type OTHER

NA Observational Registry

Propel Contour

Patients implanted with Propel Contour model implants

NA-Observational Registry

Intervention Type OTHER

NA Observational Registry

Interventions

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NA-Observational Registry

NA Observational Registry

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No