Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
Study NCT ID:
NCT07068061
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-06-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PER-SAF_PDOS (Performance and Safety of Polydioxanone Suture)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2025-06-27', 'studyFirstSubmitQcDate': '2025-07-14', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The assessment of improvement in mid-face appearance.', 'timeFrame': 'up to 24 weeks', 'description': 'Proportion of subjects with any improvement compared to baseline, as assessed by the Independend Evaluator (IE).'}], 'secondaryOutcomes': [{'measure': 'Further evaluation of improvement of the mid-face appearance.', 'timeFrame': 'up to 35 weeks', 'description': 'Proportion of subjects with any improvement compared to baseline, as assessed by the Independend Evaluator (IE).'}, {'measure': 'Self-evaluation of improvement of the mid-face appearance by the Subject.', 'timeFrame': 'up to 35 weeks', 'description': 'Proportion of subjects with any improvement compared to baseline, as assessed by the Subject.'}, {'measure': 'Number of (S)AEs.', 'timeFrame': 'up to 35 weeks', 'description': 'Number of (S)AEs evaluated by the subject using patient diary'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wrinkles', 'Anti Aging', 'Face-lift']}, 'descriptionModule': {'briefSummary': 'This clinical investigation aims to confirm the safety and efficacy of the ID in facial soft tissue reconstruction, specifically for non-incision surgery to tighten and lift the facial skin for a rejuvenated facial appearance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years old with full legal capacity, male and female;\n* Patients with ability to understand the proposed aesthetic correction and to understand and sign informed consent;\n* Patients who are willing and able to comply with scheduled visits, aesthetic correction procedure and other trial procedures.\n\nExclusion Criteria:\n\n* Pregnant or breast--feeding women;\n* Patients currently participating in any other clinical investigation;\n* Patients who have received a vaccine within 14 days prior to the baseline or plan to have vaccine within 14 days after the injection;\n* Patients with a medical history of systemic diseases, including severe kidney, liver, heart and neurological disorders.'}, 'identificationModule': {'nctId': 'NCT07068061', 'acronym': 'PER-SAF_PDOS', 'briefTitle': 'PER-SAF_PDOS (Performance and Safety of Polydioxanone Suture)', 'organization': {'class': 'INDUSTRY', 'fullName': '21 Century Medical Co., Ltd.'}, 'officialTitle': 'Evaluation of the Performance and Safety of Polydioxanone Suture (PDO) "Bio Meyisun" for the Temporary Correction of the Mid-face Area.', 'orgStudyIdInfo': {'id': 'PC-MD-CIP-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional arm', 'description': 'The procedure will start with skin cleansing using an antiseptic and careful marking of entry and exit points for thread placement. Aesthetic cream and local anaesthesia will be applied to enhance patient comfort before inserting PDO barbed threads into the subdermal layer using a cannula. The threads will be adjusted to create a natural-looking lift, followed by manual lifting to anchor them securely within the tissue. Finally, any excess thread will be trimmed, the area massaged for proper positioning, and the skin cleaned again to maintain sterility.', 'interventionNames': ['Device: PDO suture']}], 'interventions': [{'name': 'PDO suture', 'type': 'DEVICE', 'description': 'A biodegradable polymer used in dissolvable sutures and lifting threads, stimulating collagen production as it degrades.', 'armGroupLabels': ['Interventional arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Pure Clinical Sp. z o.o', 'role': 'CONTACT', 'email': 'MDsafety@pureclinical.eu', 'phone': '+48739262242'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '21 Century Medical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}