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

Product Surveillance Registry (PSR) Ear, Nose and Throat- PROPEL Drug-Eluting Sinus Stent Family EXTEND Cohort

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Rhinosinusitis (CRS)
• Intervention / Treatment: Device: Observational data collection from patients with chronic rhinosinusitis (CRS) receiving PROPEL sinus implant(s) following functional endoscopic sinus surgery (FESS)

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 Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population is the European CRS population implanted with Propel implants. Patients included in the analysis population should have a confirmed diagnosis of CRS with or without nasal polyps (NP) and are indicated for FESS (defined as total SNOT-22 score >/= 20 and Lund-Mackay score >/= 1 in each sinus intended to receive an implant. Patients should not have received biologic medication approved for treatment of CRSwNP in </= 12 weeks prior to the baseline FESS procedure, and the FESS procedure should be completed with attempted placement of 1-4 corticosteroid-eluting implants in the ethmoid sinus and/or FSO. Patients should not have had packing materials or splints of any kind placed within the implants unless medically necessary.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline (prior to FESS procedure and sinus implant) to 6 months post procedure

Collaborators and Investigators

• Sponsor: Medtronic

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: PROPEL; Corticosteroid-eluting sinus implants; Product Surveillance Registry ENT; PROPEL Mini; PROPEL Contour
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Sinusitis; Paranasal Sinus Diseases; Rhinosinusitis
• Other Study ID Numbers: EXTEND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No