Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-01-02 @ 2:59 PM
Study NCT ID:
NCT06816069
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-18
First Post:
2025-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Safety and Efficacy of Monopolar Radio Frequency Device for Facial Skin Tightening
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': 36}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-16', 'studyFirstSubmitDate': '2025-02-04', 'studyFirstSubmitQcDate': '2025-02-04', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cutometer R7 values', 'timeFrame': 'baseline, 12 weeks', 'description': 'The change in Cutometer R7 values measured on the cheeks at 12 weeks after the application of the investigational medical device compared to baseline will be evaluated.'}], 'secondaryOutcomes': [{'measure': 'Change in Cutometer R7 values', 'timeFrame': 'baseline, 8 weeks', 'description': 'The change in Cutometer R7 values measured on the cheeks at 8 weeks after the application of the investigational medical device compared to baseline will be evaluated.'}, {'measure': 'Global Aesthetic Improvement Scale (GAIS)', 'timeFrame': '4 weeks, 8 weeks, 12 weeks', 'description': 'The Global Aesthetic Improvement Scale (GAIS) assessed by both the investigator and the subjects at 4, 8, and 12 weeks after the application of the investigational medical device will be evaluated.\n\n* Minimum and Maximum Values: The GAIS ranges from -1 (worse) to +3 (excellent improvement).\n* Outcome Interpretation: Higher scores indicate a better aesthetic outcome.'}, {'measure': 'Numeric Rating Scale (NRS) for Pain', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, 12 weeks', 'description': "The subject's pain level at the treatment site will be evaluated using the Numeric Rating Scale (NRS) at the baseline visit and at 4, 8, and 12 weeks after the application of the investigational medical device.\n\n* Minimum and Maximum Values: The NRS ranges from 0 (no pain) to 10 (worst imaginable pain).\n* Outcome Interpretation: Higher scores indicate worse pain."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VOLNEWMER', 'Monopolar radiofrequency device', 'MRF', 'Skin Tightening', 'Facial skin treatment', 'Skin Elasticity'], 'conditions': ['Skin Aging']}, 'descriptionModule': {'briefSummary': 'Objective:\n\nThe goal of this clinical trial is to evaluate the safety and efficacy of the VOLNEWMER monopolar radiofrequency device developed by CLASSYS Inc. This study is a prospective, single-center, single-arm, pilot clinical trial.\n\nResearch Questions:\n\n1. Does the VOLNEWMER device improve skin elasticity?\n2. Is the safety profile of the VOLNEWMER device acceptable?\n\nSubject Procedures:\n\nSubjects will:\n\n* Receive a single treatment session using the VOLNEWMER device.\n* Attend follow-up visits over a 12-week period to assess improvements in elasticity and safety.\n\nThe primary outcome is the improvement in skin elasticity of the face and cheeks, measured 12 weeks after treatment using the Cutometer R7. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS). Safety assessments involve monitoring treatment-emergent adverse events (TEAEs) associated with the application of the investigational medical device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who are aged 19 to under 65 at the time of consent.\n* Subjects who seek improvement in facial skin elasticity (both cheeks).\n* Subjects who agree not to undergo other procedures affecting skin elasticity during the study.\n* Subjects who provide written consent and commit to full trial participation.\n\nExclusion Criteria:\n\n* Subjects with conditions at the investigational device application site (e.g., scars, open wounds, metal stents, or implants, that could affect the trial)\n* Subjects with inappropriate skin conditions or treatment history\n* Subjects with allergies or predispositions\n* Subjects using inappropriate medications that have the potential to increase the risk of bleeding or delay skin healing.\n* Subjects with lifestyle or other unsuitable conditions (Smoking history, participation in another interventional clinical trial prior to screening, not agreeing to use medically acceptable contraception, pregnant or breastfeeding women)\n* Subjects deemed inappropriate by the investigator'}, 'identificationModule': {'nctId': 'NCT06816069', 'briefTitle': 'Study on Safety and Efficacy of Monopolar Radio Frequency Device for Facial Skin Tightening', 'organization': {'class': 'INDUSTRY', 'fullName': 'CLASSYS Inc.'}, 'officialTitle': 'Early Stage Safety and Efficacy Assessment for the Temporary Facial(both Cheeks) Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device: Prospective, Open-label, Single Center, Single-arm, Pilot Clinical Trial', 'orgStudyIdInfo': {'id': 'VM-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VOLNEWMER', 'description': "Each subject will undergo a procedure using VOLNEWMER's F-Tip or V-tip electrode with either the Basic mode or Easy mode, depending on the treatment area.", 'interventionNames': ['Device: VOLNEWMER']}], 'interventions': [{'name': 'VOLNEWMER', 'type': 'DEVICE', 'description': 'Monopolar radiofrequency device', 'armGroupLabels': ['VOLNEWMER']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06974', 'city': 'Dongjak-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Chung-Ang University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CLASSYS Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}