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

Withdrawn

• Conditions: Chronic Rhinosinusitis (CRS)

• Registration Number: NCT06671561
• Lead Sponsor: Medtronic

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-01
• Study First Posted: 2024-11-04
• Study Start: 2025-01-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-08
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To characterize the SNOT-22 total score change from baseline to Month 6 in patients with CRS undergoing FESS	From baseline (prior to FESS procedure and sinus implant) to 6 months post procedure	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.