PSR ENT base
Research type
Research Study
Full title
Ear, Nose & Throat (ENT) Product Surveillance Registry (PSR) platform base clinical investigation plan PROPEL Drug-Eluting Sinus Stent Family Addendum
IRAS ID
324422
Contact name
Hesham Saleh
Contact email
Sponsor organisation
Medtronic Inc.
Duration of Study in the UK
2 years, 4 months, 13 days
Research summary
Research Summary:
A total of 215 adults with chronic sinus disease took part in the study. The study looked at the safety and effectiveness of PROPEL™ family sinus implants in patients undergoing sinus surgery.
Patients reported a meaningful improvement in their sinus symptoms and quality of life six months after treatment, and these improvements were sustained through 12 months. The need for additional treatment with oral steroids or further surgical treatment was low during the 12-month follow-up period.
Adverse events were reported in a small number of patients. Nine of the 204 patients included in the safety assessment experienced an adverse event. The most commonly reported event was sinusitis, followed by headache and nosebleeds. Most events were not serious. One serious adverse event involving an infection was reported, and no deaths were reported during the study.
Overall, the study showed sustained improvements in sinus symptoms and quality of life, together with a low rate of adverse events, in patients who received PROPEL™ family sinus implants following sinus surgery.The PSR registry is an ongoing record of the experience from people around the world treated with a Medtronic product and its performance. It will be used to support post-market surveillance activities and post-approval studies, e.g. to collect safety and performance information as required by regulations applicable to Medtronic. In addition, it will be used to obtain clinical evidence for the development and improvement of medical devices, therapies, device guidelines, patient services/solutions and provide clinical data to support health economics and clinical outcomes research.
The registry is not an experimental clinical study. For this registry, we will only be collecting data, assessed in a "real-life" environment and therefore the duration of data collection will be determined by the product received by the patient.
This submission is for patients who have been, or are due to be, treated with a Medtronic market-approved Ear, nose & Throat (ENT) device (PSR Surgical Base CIP).
The first accompanying addendum for the ENT base protocol is the PROPEL Drug-Eluting Sinus Stent Family, to confirm the long-term clinical safety and
performance, acceptability of identified risks, and to detect emerging risks based
on factual evidence for the PROPEL family of products when used according to
labeling (in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery). Additionally, this study
intends to collect data on use of corticosteroid-eluting implants in the European
CRS population. Data collected will be used to ensure continued consistency
between clinical data, the information materials supplied by the manufacturer, and
the risk management documentation.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
23/EM/0081
Date of REC Opinion
20 Apr 2023
REC opinion
Further Information Favourable Opinion