Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT07041918
Status:
COMPLETED
Last Update Posted:
2025-11-28
First Post:
2025-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Performance and Safety of VACUSERA® PRP Tubes in the Preparation of Autologous Platelet-Rich Plasma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-06-19', 'studyFirstSubmitQcDate': '2025-06-19', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increasing platelet concentration', 'timeFrame': 'Day 1: Blood will be taken on the same day and sent for analysis for counting.', 'description': 'Approximately 8 ml (±10%) of blood will be collected to the PRP Tubes and approximately 7 ml (±10%) to the PRP Tube with Gel, and platelet (PLT) count will be performed on the obtained plasma, with the concentration increase relative to whole blood analyzed.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['No Disease or Condition is Being Studied']}, 'descriptionModule': {'briefSummary': "Study Design After the eligibility assessment during screening and obtaining a written informed consent form, the volunteers' demographic information and medical history will be recorded.\n\nIn addition to the hemogram and pregnancy test to be performed on the volunteers in this study, an additional tube (approximately 8 ml (±10%) for the VACUSERA® Single PRP Tube or approximately 7 ml (±10%) for the VACUSERA® Single Gel PRP Tube) will be used to obtain platelet-rich plasma (PRP). After centrifugation of the PRP tubes, the platelet (PLT) count in the resulting plasma will be analyzed, and the concentration increase in relation to whole blood will be evaluated.", 'detailedDescription': 'The study is a post-market clinical follow-up (PMCF) study aimed at proving the effectiveness and safety of PRP tubes that are already CE (European Conformity) certified and released on the market. After the eligibility assessment during screening and obtaining the written informed consent form, the demographic information and medical history of eligible volunteers will be recorded on a paper case report form.\n\nThe analysis conducted using the G-Power power test calculated that the number of patients to be included in the study is 194.In addition to the hemogram and pregnancy test to be performed on the volunteers in this study, an additional tube (approximately 8 ml (±10%) for the VACUSERA® Single PRP Tube or approximately 7 ml (±10%) for the VACUSERA® Single Gel PRP Tube) will be used to obtain platelet-rich plasma (PRP). After centrifugation of the PRP tubes, platelet (PLT) count will be performed on the obtained plasma, and the concentration increase relative to whole blood will be analyzed.\n\nScreening Day (Day 1):\n\nVolunteers will undergo a medical history review to check eligibility for inclusion in the study.\n\nAnalysis Day (Day 1):\n\nA single blood sample will be collected for platelet (hemogram) testing, and for women of reproductive age, a beta HCG (human chorionic gonadotropin) test will be conducted.\n\nPlatelet (PLT) count will be performed on the plasma obtained from the blood sample collected in the PRP tubes.\n\nThe concentration increase in the resulting plasma will be analyzed in relation to whole blood.The PRP results of volunteers who do not meet the inclusion criteria based on hemogram test results or who are pregnant will not be included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female volunteers between the ages of 18 and 60, as defined in the target population during screening,', 'healthyVolunteers': True, 'eligibilityCriteria': "INCLUSION CRITERIA\n\nMale or female volunteers between the ages of 18 and 60, as defined in the target population during screening,\n\nBody Mass Index (BMI) between 18 and 32 during screening,\n\nNo pregnancy or risk of pregnancy for women,\n\nWilling to participate and provide written informed consent and comply with the study restrictions,\n\nMust not have participated in any clinical trial within 2 months prior to the start of the study,\n\nMust be able to communicate with the researcher or authorized personnel.\n\nEXCLUSION CRITERIA\n\nPlatelet dysfunction syndrome,\n\nCritical thrombocytopenia,\n\nHemodynamic instability,\n\nSepticemia,\n\nLocal infection at the site of the procedure,\n\nAutoimmune diseases,\n\nHistory of chronic infections,\n\nChronic liver pathology,\n\nPatients receiving anticoagulant/antiplatelet therapy,\n\nUse of NSAIDs (except for paracetamol) in the last 7-10 days,\n\nHistory of alcohol and/or drug addiction,\n\nCorticosteroid use,\n\nFever or illness in the past week,\n\nCancer (especially blood and bone cancers),\n\nHemoglobin (HGB) levels below 10 g/dl or above 16.5 g/dl in men and 16 g/dl in women,\n\nPlatelet count below 105/μl,\n\nThose under immunosuppressive therapy,\n\nAny condition or disease detected during the medical interview/physical examination that, in the opinion of the researcher or designated personnel, would make the volunteer unsuitable for the study, put them at unnecessary risk, or interfere with the volunteer's ability to complete the study,\n\nClinically significant deviation from normal findings in the physical examination, including vital signs,\n\nPatients planning pregnancy or not using contraception,\n\nPatients using hormonal contraceptive methods to prevent pregnancy,\n\nBreastfeeding women,\n\nPoor venous access for blood sampling,\n\nPlasma or blood donation within the last 2 months,\n\nIt is recommended to select patients who do not use tobacco products during the study, as it is considered that it may affect the product's performance."}, 'identificationModule': {'nctId': 'NCT07041918', 'acronym': 'PRP', 'briefTitle': 'Evaluation of the Performance and Safety of VACUSERA® PRP Tubes in the Preparation of Autologous Platelet-Rich Plasma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Disera Tıbbi Cihazlar Lojistik Sanayi ve Ticaret A.Ş'}, 'officialTitle': 'Evaluation of the Performance and Safety of VACUSERA® PRP Tubes in the Preparation of Autologous Platelet-Rich Plasma: A Prospective, Observational Medical Device Study (PMCF)', 'orgStudyIdInfo': {'id': '0.PRT.KGV.002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'The study is entirely designed to analyze product performance (analyze only results from whole blood and derived from the PRP tubes), and no interventions will be performed.', 'type': 'DEVICE', 'description': 'The study will evaluate and analyze only the results obtained from whole blood in the hemogram test and the results derived from the PRP tubes. The main objective is to measure the performance of the Vacusera PRP Tube and Vacusera PRP Tube with Gel in obtaining platelet-rich plasma. The study is entirely designed to analyze product performance, and no interventions will be performed.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35575', 'city': 'Izmir', 'state': 'Karşıyaka', 'country': 'Turkey (Türkiye)', 'facility': 'Medical Point Hastanesi Klinik Araştırmalar Merkezi', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Recep Selim Şentürk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Point Hastanesi Klinik Araştırmalar Merkezi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Disera Tıbbi Cihazlar Lojistik Sanayi ve Ticaret A.Ş', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}