Propel Drug-Eluting Sinus Stent Family Open Cohort

Medtronic215 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

215

Conditions

Chronic Rhinosinusitis (Diagnosis)

Interventions

NA-Observational RegistryOTHER

NA Observational Registry

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Saint Elisabeth Krankenhaus Köln-Hohenlind

Cologne, Germany

Universitätsklinikum Freiburg Klinik für Hals, Nasen und Ohrenheilkunde

Freiburg im Breisgau, Germany

Katholisches Krankenhaus Hagen

Hagen, Germany

Outcomes

Primary Outcomes

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

The primary efficacy endpoint is Sino-Nasal Outcome Test 22 item (SNOT-22) total score change from baseline to Month 6. The SNOT-22 assesses 22 symptoms associated with Chronic Rhinosinusitis (CRS) with a value from 0 (no problem) to 5 (problem as bad as it can be). The total score is assessed by summing the score for each of the 22 items. Total SNOT-22 scores of 20 and greater in patients with CRS meet criteria defined by European Position Paper on Rhinosinusitis and Nasal Polyps 2020 (EPOS 2020) as indicated for Functional Endoscopic Sinus Surgery (FESS). Baseline SNOT-22 total scores are expected to be higher at baseline prior to FESS. A decrease in SNOT-22 score at 6 months would indicate improvement in the patient's CRS symptoms.

Time frame: 6 months

Secondary Outcomes

Endoscopic evaluation

Endoscopic evaluation scoring from baseline to month 3, 6, and12. Endoscopic evaluation is the physician's assessment via endoscopy of the adhesion/scarring, polyps, patency, polypoid oedema, and middle turbinate lateralization of the sinuses from 0 (none) to 3-4 (most severe) prior to FESS, and following FESS and Propel stent placement at 3, 6 and 12 months. Lower scores at follow-up would indicate improvement in the patient's CRS and healing compared to baseline.

Time frame: 12 months

Data from ClinicalTrials.gov

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