[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534783":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":13,"responsibleParty":26,"collaborators":7,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":32,"acronym":7,"eligibilityCriteria":33,"healthyVolunteers":34,"sex":35,"minAge":36,"maxAge":7,"enrollmentInfo":37,"targetDuration":7,"studyType":40,"phases":7,"briefSummary":41,"conditions":42,"keywords":7,"overallStatus":44,"whyStopped":7,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":54},{"fullName":5,"class":6},"AQTIS Medical B.V.","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","Ellansé-S","It is indicated for subcutaneous implantation to correct moderate-to-severe NLFs",[14],{"facility":15,"status":7,"city":16,"state":17,"zip":7,"country":18,"countryCode":19,"cosmosGeoPoint":20,"geoPoint":25,"contacts":7},"Guangdong Second People's Hospital","Guangzhou","Guangdong","China","CN",{"type":21,"coordinates":22},"Point",[23,24],113.25,23.11667,{"lat":24,"lon":23},{"type":27,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100534783","a-prospective-multicenter-post-marketing-clinical-follow-up-research-to-evaluate-the-long-term-safety-of-ellans-s-dermal-filler-made-of-pcl-microspheres-for-the-correction-of-moderate-to-severe-nasolabial-folds-100534783",false,"NCT06243315","A Prospective, Multicenter, Post-marketing Clinical Follow-up Research to Evaluate the Long-term Safety of Ellansé-S Dermal Filler Made of PCL Microspheres for the Correction of Moderate-to-severe Nasolabial Folds","Inclusion Criteria:\n\n1. 18 years old and above;\n2. Subjects with moderate-to-severe nasolabial folds (3-4 level of WSRS scores) on both sides of the face\n3. Intended to be treated with PCL microsphere filler;\n4. Voluntarily participate in this test, cooperate with follow-up, and sign an informed consent form\n\nExclusion Criteria:\n\n1. Obvious acne scar, pigmentation, active infection, inflammation, tumor, precancerous lesion or unhealed wound in the intended injection area;\n2. Patients who have used permanent fillers (PMMA, hydrogel polymer, liquid silicone for injection, polyvinyl alcohol (PVA), bone cement, autologous fat, etc.) for nasolabial groove injection;\n3. Patients who have received semi-permanent fillers (polycaprolactone, L-polylactic acid, hydroxyapatite, platelet-rich plasma, etc.) injection treatment in nasolabial sulch area in the past 24 months;\n4. Patients who have received temporary fillers (hyaluronic acid, collagen, etc.) injection treatment in nasolabial groove in the past 12 months;\n5. Patients who have received botox injection treatment in nasolabial sulci in the past 6 months;\n6. The nasolabial groove has been treated with beauty plastic, focused ultrasound, chemical stripping, photoelectric (laser, photon, radio frequency) in the past 3 months;\n7. Use of hormones or immunosuppressants within the past 1 month;\n8. Subjects who have used anticoagulants in the last 2 weeks;\n9. Subjects with a history of crabfoot, hyperplastic scars or cicatricial constitution;\n10. Subjects with active sepsis;\n11. Subjects with coagulation dysfunction;\n12. Subjects with autoimmune diseases;\n13. Allergic to polycaprolactone or known product ingredients;\n14. Pregnant, pregnant and lactating subjects;\n15. Participated in other clinical trials in the past 30 days;\n16. Other situations determined by the researcher to be unsuitable for participation in this study;",true,"ALL","18 Years",{"count":38,"type":39},374,"ESTIMATED","OBSERVATIONAL","This research is intended to evaluate the long-term safety of Ellansé-S PCL dermal filler for the correction of moderate-to-severe NLFs.\n\n374 subjects. This clinical trial is designed as a prospective, multicenter, post-marketing clinical follow-up trial to evaluate the long-term safety of the investigational product, dermal filler made of PCL microspheres, for the correction of moderate-to-severe NLFs",[43],"Moderate-to-severe Nasolabial Folds (3-4 Level of WSRS Scores) on Both Sides of the Face","ENROLLING_BY_INVITATION","2025-04-25",{"date":47,"type":48},"2025-04-29","ACTUAL",{"date":50,"type":48},"2023-10-12",{"date":52,"type":39},"2029-09",{"name":5,"class":6},1]