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

NCT ID: NCT06671561

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-30
• Study Completion Date: 2027-04-30

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.

Conditions

Chronic Rhinosinusitis (CRS)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Observational data collection

Intervention Type: DEVICE

Eligibility Criteria

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

Sponsors

Medtronic

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

EXTEND

Identifier Type: -

Identifier Source: org_study_id