[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614180":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":59,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":26,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Hospital Universitario Pedro Ernesto","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: Foam only","ACTIVE_COMPARATOR","Polidocanol 0,5% foam prepared with 1 mL of sclerosant and 3 mL of room air, injected under visualization of reticular vein (5 - 8 mL total).",[13],"Drug: Polidocanol foam sclerotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B: Foam + Laser","EXPERIMENTAL","Polidocanol 0,25% foam (1 mL of sclerosant + 2 mL of room air) followed within 2 minutes by long-pulse Nd:YAG 1064 nm laser (spot 6 mm; pulse 20-30 ms; fluence 60-70 J\u002Fcm²), with skin cooling.",[13,19],"Device: Transdermal Nd:YAG 1064 nm laser",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Polidocanol foam sclerotherapy","Polidocanol foam prepared using the Tessari method. Concentration 0,5% (Foam Arm) or 0,25% (Foam + Laser Arm), injected under ultrasound guidance.",[9,15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DEVICE","Transdermal Nd:YAG 1064 nm laser","Long-pulse Nd:YAG 1064 nm transdermal laser applied along the treated vein path immediately after foam injection.",[15],[33],{"name":34,"affiliation":35,"role":36},"Juliana Vieira, PhD","Hospital Universitário Pedro Ernesto - UERJ","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Juliana de Miranda Vieira, PhD","CONTACT","+ 55 21 99972 2885","juliana.vieira@hupe.uerj.br",[44],{"facility":35,"status":45,"city":46,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Rio de Janeiro","20551-030","Brazil","BR",{"type":51,"coordinates":52},"Point",[53,54],-43.18223,-22.90642,{"lat":54,"lon":53},[57],{"name":39,"role":40,"phone":58,"phoneExt":26,"email":42},"+ 55 21 999722885",{"type":36,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Juliana de Miranda Vieira","Principal Investigator","100614180","polidocanol-foam-with-or-without-transdermal-laser-in-varicose-veins-100614180",false,"NCT07276243","Polidocanol Foam With or Without Transdermal Laser in Varicose Veins","Comparação da eficácia clínica e estética Entre o Tratamento de Varizes Com Espuma de Polidocanol Associada ou não ao Laser transdérmico: Ensaio clínico Randomizado","FOAM-LASER","Inclusion Criteria:\n\n* Age 21 to 75 years\n* CEAP clinical class 1-3\n* Lower limb tributary varicose veins 2,5 to 4,0 mm in diameter on Doppler ultrasound.\n* Vein depth up to 4 mm from the skin surface.\n* Tributary vein may originate from the great or small saphenous vein as long as the saphenous vein is competent on Doppler.\n* Reflux limited to the target tributary.\n* Body mass index (BMI) \\\u003C 35 km²\u002Fm²\n* Able and willing to provide informed consent.\n\nExclusion Criteria:\n\n* CEAP clinical class ≥ 4\n* Axial reflux of the great or small saphenous vein requiring prior treatment\n* Tributary vein diameter \\\u003C 2.5 mm or \\> 4.0 mm on Doppler\n* Tributary vein depth \\> 4 mm from the skin surface\n* Pregnancy or breastfeeding\n* Known allergy or hypersensitivity to polidocanol\n* History of deep vein thrombosis or pulmonary embolism in the last 6 months\n* Use of anticoagulant therapy that cannot be safely interrupted\n* Active skin infection or ulcer at the treatment site\n* Autoimmune or connective tissue disease with active vasculitis\n* BMI ≥ 35 kg\u002Fm²\n* Inability to comply with follow-up visits\n* Previous treatment of the target vein in the past 6 months (laser, foam, surgery, or microphlebectomy).","ALL","21 Years","75 Years",{"count":74,"type":75},102,"ESTIMATED","INTERVENTIONAL",[78],"NA","This randomized, parallel clinical trial with blinded outcome assessment will compare the clinical and aesthetic outcomes of polidocanol foam sclerotherapy alone versus polidocanol foam associated with long-pulse 1064 nm Nd:YAG transdermal laser in the treatment of lower-limb tributary varicose veins. The primary endpoint is venous occlusion rate at 30 days, assessed by Doppler ultrasound. Secondary outcomes include cutaneous hyperpigmentation, pain, patient satisfaction, and adverse events.",[81],"Varicose Veins","2026-04-29",{"date":84,"type":85},"2026-05-05","ACTUAL",{"date":87,"type":85},"2026-03-24",{"date":89,"type":75},"2027-12-30",{"name":5,"class":6},1]