Product Surveillance Registry; Ear, Nose and Throat - EXTEND Cohort

Medtronic

Overview

The purpose of this study is to confirm long-term clinical safety and performance, acceptability of identified risks, and detect emerging risks based on factual evidence for the PROPEL family of products when used according to labeling in a real-world setting.

Ongoing clinical investigation for the purpose(s) of: * Providing continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products for their intended use * Obtaining real-world performance and safety information from a global network of hospitals, clinics, and clinicians intended to represent the range of clinical environments in which Medtronic products are used * Supporting post-market surveillance activities and post-approval studies that are initiated by Medtronic, regulated by local governments, or are conducted to fulfill government and/or regulatory authority requests * Obtaining clinical evidence to guide the development and improvement of medical devices, therapies, device guidelines, and patient services/solutions * Providing clinical data to support health economics and clinical outcomes research Enrollment is estimated to take place at up to 10 sites in Europe over 12 months. A single site may enroll no more than 30 patients. Patients may be enrolled up to 60 days prior to the baseline procedure. Subjects will be followed for a total duration of12 months postoperatively.

Study Type

OBSERVATIONAL

Conditions

Chronic Rhinosinusitis (CRS)

Interventions

Observational data collection from patients with chronic rhinosinusitis (CRS) receiving PROPEL sinus implant(s) following functional endoscopic sinus surgery (FESS)DEVICE

Observational data collection

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

Outcomes

Primary Outcomes

To characterize the SNOT-22 total score change from baseline to Month 6 in patients with CRS undergoing FESS

The primary objective is to characterize the 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. Baseline SNOT-22 total scores are expected to be higher prior to Functional Endoscopic Sinus Surgery (FESS) and implant of the sinus implant(s) . A decrease in SNOT-22 score at 6 months would indicate improvement in the patient's CRS symptoms.

Time frame: From baseline (prior to FESS procedure and sinus implant) to 6 months post procedure

Data from ClinicalTrials.gov

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