Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2026-01-25 @ 2:45 PM
Study NCT ID:
NCT06671561
Status:
WITHDRAWN
Last Update Posted:
2025-05-15
First Post:
2024-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Product Surveillance Registry; Ear, Nose and Throat - EXTEND Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'New study design and data collection needed', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2024-11-01', 'studyFirstSubmitQcDate': '2024-11-01', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': "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."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['PROPEL', 'Corticosteroid-eluting sinus implants', 'Product Surveillance Registry ENT', 'PROPEL Mini', 'PROPEL Contour'], 'conditions': ['Chronic Rhinosinusitis (CRS)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Ongoing clinical investigation for the purpose(s) of:\n\n* Providing continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products for their intended use\n* 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\n* 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\n* Obtaining clinical evidence to guide the development and improvement of medical devices, therapies, device guidelines, and patient services/solutions\n* Providing clinical data to support health economics and clinical outcomes research\n\nEnrollment 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.\n* Patient has or is intended to receive or be treated with an eligible Medtronic product\n* Patient is consented within the enrollment window of the therapy received, as applicable\n\nExclusion Criteria:\n\n* Patient who is, or is expected to be, inaccessible for follow-up\n* Participation is excluded by local law\n* Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results'}, 'identificationModule': {'nctId': 'NCT06671561', 'briefTitle': 'Product Surveillance Registry; Ear, Nose and Throat - EXTEND Cohort', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic'}, 'officialTitle': 'Product Surveillance Registry (PSR) Ear, Nose and Throat- PROPEL Drug-Eluting Sinus Stent Family EXTEND Cohort', 'orgStudyIdInfo': {'id': 'EXTEND'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observational data collection from patients with chronic rhinosinusitis (CRS) receiving PROPEL sinus implant(s) following functional endoscopic sinus surgery (FESS)', 'type': 'DEVICE', 'description': 'Observational data collection'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}