[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mild-defects-of-the-lips\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mild-defects-of-the-lips":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100656739","post-market-clinical-follow-up-pmcf-study-of-safety-and-performance-of-300-01-refillha-lips-100656739",false,"NCT07831213","Post-Market Clinical Follow-up (PMCF) Study of Safety and Performance of 300-01 RefillHA Lips","A Post-Market Observational Study of the Safety and Efficacy of RefillHA Lips for Remodelling and Correction of Mild Defects of the Lips.","Inclusion Criteria:\n\n* Men or women of any race, 18 years of age or older.\n* Able to read, understand and sign informed consent.\n\nExclusion Criteria:\n\n* Subjects with known contraindications to the treatment with RefillHA Lips, as per the device IFU.\n* Patients with multiple and\u002For severe allergies or history of anaphylaxis.\n* Pregnant or lactating women (contraindications as per IFU).\n* Having received prior dermal filler injections in the six months preceding the study.\n* Previously treated with semi-permanent or permanent filler in the intended injection area.\n* Presenting with a cutaneous disorder, inflammation or infection near to the treatment area.\n* Known hypersensitivity to lidocaine and\u002For lidocaine HCl or hyaluronic acid.\n* Metabolic or endocrine uncontrolled disease, anaphylaxis, severe allergies or uncontrolled immune disorder.\n* Undergoing or planning to undergo peeling treatment or laser-\u002Fultrasound-based treatment within 3 weeks before or after injection.\n* Have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti- inflammatory drugs (NSAIDs such as aspirin, ibuprofen), or other substances known to prolong time of coagulation from a week before treatment. A wash-out period of a week is allowed.\n* Subject who has a condition or is in a situation that, in the investigator's opinion, may put the subject at significant risk, or may significantly interfere with the subject's participation in the study or with protocol evaluation parameters.","ALL","18 Years",{"count":19,"type":20},87,"ESTIMATED","OBSERVATIONAL","A Post-Market Observational Study of the Safety and Efficacy of RefillHA Lips for Remodelling and Correction of Mild Defects of the Lips",[24],"Mild Defects of the Lips",[26],"Mild defects of the lips","RECRUITING","2026-09-15",{"date":30,"type":31},"2026-09-21","ACTUAL",{"date":33,"type":31},"2024-01-18",{"date":35,"type":20},"2027-02-25",{"name":37,"class":38},"Glyance","INDUSTRY"]