Clinical trial NCT06671561: Product Surveillance Registry; Ear, Nose and Throat - EXTEND Cohort
Official title: Product Surveillance Registry (PSR) Ear, Nose and Throat- PROPEL Drug-Eluting Sinus Stent Family EXTEND Cohort
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Rhinosinusitis (CRS)
Keywords: PROPEL
Corticosteroid-eluting sinus implants
Product Surveillance Registry ENT
PROPEL Mini
PROPEL Contour
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: To characterize the SNOT-22 total score change from baseline to Month 6 in patients with CRS undergoing FESS
timeFrame: From baseline (prior to FESS procedure and sinus implant) to 6 months post procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: