[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"venous-malformations\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:venous-malformations":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,74,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100644438","phase-2-acetylsalicylic-acid-versus-placebo-as-an-add-on-treatment-to-local-non-steroidal-anti-inflammatory-drug-for-the-management-of-thrombotic-episodes-in-superficial-venous-malformations-in-children-aged-6-to-17-years-100644438",false,"NCT07663825","Acetylsalicylic Acid Versus Placebo as an add-on Treatment to Local Non-steroidal Anti-inflammatory Drug for the Management of Thrombotic Episodes in Superficial Venous Malformations in Children Aged 6 to 17 Years.","Acetylsalicylic Acid Versus Placebo as an add-on Treatment to Local Non-steroidal Anti-inflammatory Drug for the Management of Thrombotic Episodes in Superficial Venous Malformations in Children Aged 6 to 17 Years: a Controlled Randomised, Double-blind, Cross-over, Multicenter Trial","ASPIRIN","Inclusion Criteria:\n\n* Patients aged 6 to 17 years\n* Weight ≥ 20 kg\n* Isolated or combined superficial venous malformation, confirmed by imaging, with the presence of phleboliths indicating the occurrence of previous superficial venous thrombosis\n* Complicated by acute thrombotic episodes (2 or more in the previous 12 months)\n* Written consent of the child's legal representatives or of the participant if over 18 years of age\n* Affiliation of a social security scheme\n* Highly effective contraception for young women of childbearing age\n\nExclusion Criteria:\n\n* Patients with deep or syndromic venous malformation\n* Patients with known G6PD deficiency\n* Patients with known mastocytosis\n* History of hemarthrosis\n* Simultaneous participation in another biomedical study\n* Constitutional or acquired haemostasis pathology\n* Current treatment affecting haemostasis (anticoagulants, platelet anti aggregants, oral NSAIDs)\n* Frequent bleeding (epistaxis, other) requiring management\n* Basic treatment of venous malformation (mTOR inhibitor)\n* Active neoplasia or infection (altered coagulation balance)\n* Known allergy to acetylsalicylic acid\n* Injured skin, whatever the lesion: oozing dermatitis, eczema, infected lesions, burns or wounds\n* Pregnant and breastfeeding women\n* Severe renal insufficiency, severe hepatic insufficiency, severe uncontrolled cardiac insufficiency\n* Methotrexate ≥ 20 mg\u002Fweek","ALL","6 Years","17 Years",{"count":21,"type":22},34,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Superficial venous malformations (SVMs) are rare congenital anomalies that present as bluish masses. These masses may be focal, with limited skin involvement, or segmental, with more extensive involvement. They may be associated with syndromic conditions such as blue rubber nevus syndrome.\n\nSVMs are characterised by a progressive worsening course, with repeated episodes of superficial venous thrombosis occurring. These episodes become more frequent over time, causing acute, intense and often highly debilitating pain.\n\nTo limit progression and in cases of functional impairment, long-term treatments may be offered. These include venous compression, targeted therapies such as mTOR inhibitors, and, where possible, surgical treatment or sclerotherapy.\n\nHowever, the management of intra-SVM superficial venous thrombosis is not currently standardised, especially in the pediatric population. This study aims to evaluate the benefits of Acetylsalicylic acid (ASA) as an add-on treatment to local non-steroidal anti-inflammatory drug for the management of thrombotic episodes in superficial venous malformations in children aged 6 to 17 years.",[28,29],"Venous Malformation, Low Flow","Venous Malformations",[31,32,33],"superficial venous thrombosis","superficial venous malformations","acetylsalicylic acid","NOT_YET_RECRUITING","2026-06-16",{"date":37,"type":38},"2026-06-23","ACTUAL",{"date":40,"type":22},"2026-09",{"date":42,"type":22},"2030-10-31",{"name":44,"class":45},"University Hospital, Tours","OTHER",6,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100624056","microwave-ablation-for-treatment-of-vascular-malformations-efficacy-and-safety-100624056","NCT07404670","Microwave Ablation for Treatment of Vascular Malformations: Efficacy and Safety","A Multicenter, Prospective Study to Analyze the Efficacy and Safety of Microwave Ablation for the Treatment of Vascular Malformations","Inclusion Criteria:\n\n1. Patients with clinically diagnosed vascular malformations (venous malformations (VM) or arteriovenous malformations (AVM)) confirmed by MRI or ultrasound.\n2. Presence of symptomatic lesions (pain, swelling, functional impairment, or ulceration) that require treatment.\n3. Lesions that are amenable to microwave ablation based on preoperative clinical and imaging assessment.\n4. Ability to provide informed consent or parental consent for minors (if applicable).\n\nExclusion Criteria:\n\n1. Capillary malformations or congenital arteriovenous fistula.\n2. Lesions that are too close to critical structures (e.g., major blood vessels or nerves) and cannot be safely treated.\n3. Pregnancy or breastfeeding.\n4. Severe coagulopathy or significant bleeding disorders.\n5. Active infection at the treatment site.\n6. Patients with severe uncontrolled systemic disease that could interfere with treatment or recovery.\n7. Recent treatments (e.g., surgery, sclerotherapy, embolization) for the same lesion within the last 6 months.",{"count":55,"type":22},150,[57],"NA","This clinical trial aims to assess the safety and efficacy of microwave ablation in treating vascular malformations, including both venous malformations (VM) and arteriovenous malformations (AVM). Vascular malformations are abnormal clusters of blood vessels that can cause pain, swelling, and functional impairment, significantly affecting a patient's quality of life. Microwave ablation is a minimally invasive treatment that uses heat to shrink abnormal vessels, but its effectiveness and safety for these conditions need further investigation.\n\nThe trial will enroll 150 patients (100 with venous malformations and 50 with arteriovenous malformations), all of whom will undergo a single session of microwave ablation. Ultrasound guidance will be used during the procedure to precisely target the lesions, while MRI will be used for both preoperative and postoperative evaluations to assess lesion size and track changes over time.\n\nThe primary goals of the study are to determine whether microwave ablation can reduce lesion size and improve symptoms such as pain and swelling. Additionally, the study will monitor adverse events to evaluate the safety of the procedure, including any potential complications like infection, bleeding, or nerve injury.\n\nPatients will be followed for 12 months, with MRI scans taken at 1 month, 3 months, 6 months, and 12 months after the procedure to evaluate lesion shrinkage and monitor for any recurrence. Clinical symptoms will also be assessed at these time points to track improvement.\n\nThis study could provide important data on the safety and efficacy of microwave ablation, potentially offering a less invasive treatment option for patients with vascular malformations.",[29,60,61,62],"Arteriovenous Malformations","Microwave Ablation","Vascular Malformations",[61,62,29,60,64],"Minimally Invasive Treatment","2026-02-05",{"date":67,"type":38},"2026-02-11",{"date":69,"type":22},"2026-03-01",{"date":71,"type":22},"2028-03-01",{"name":73,"class":45},"Chengdu University of Traditional Chinese Medicine",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100614854","phase-3-a-study-to-investigate-efficacy-and-safety-of-kp-001-compared-with-placebo-in-patients-aged-2-years-with-common-vm-common-lm-or-ktscloves-syndrome-100614854","NCT07285005","A Study to Investigate Efficacy and Safety of KP-001 Compared With Placebo in Patients Aged ≥2 Years With Common VM, Common LM, or KTS\u002FCLOVES Syndrome","A Phase 3, Randomized, Parallel, Multicenter, Double-blind, Placebo-controlled Study to Investigate Efficacy and Safety of KP 001 in Patients Aged ≥2 Years With Common Venous Malformations, Common Lymphatic Malformations, or KTS\u002FCLOVES Syndrome","S-KY","Inclusion Criteria:\n\n1. Patients aged 2 years or older at the time of consent or assent.\n2. Patients diagnosed with ISSVA classification of common VM, common (cystic) LM (including mixed type consisting mainly of either VM or LM), or KTS\u002FCLOVES syndrome.\n3. Patients who cannot be cured by resection, who are difficult to resect based on the assessment of the Investigator, or who are considered refractory to available treatment by the Investigator, or who have a contraindication to available treatment.\n4. Patients with at least one target lesion at least 4 cm in the longest diameter.\n5. Patients with at least one MRI-volumetric target lesion at screening that is determined to be evaluable by the central imaging evaluator.\n6. Patients with symptomatic disease, defined as:\n\n   ・ For patients ≥8 years old: Pain NRS of ≥1 and ≤8 score at the screening visit will be eligible only if their daily pain NRS recorded via ePRO from screening to Day 1 (Week 0) does not show a maximum absolute change of ≥6 points. If patients are taking analgesic medication, there must be no change in the type or dosage of analgesic during the screening period. If patients do not have qualifiable pain, then Fatigue or Bleeding\u002FOozing NRS of ≥1 and ≤8 score at the screening visit is required. Patients with ≥6 points absolute change in pain NRS are eligible if at least one of either Fatigue OR Bleeding\u002FOozing NRS is ≥1 and ≤8.\n   * For patients ≥3 years old to \\\u003C8 years old: Wong-Baker FACES pain rating scale equal to or greater than 2 points at screening visit. Patients who are ≥3 years old to \\\u003C8 years old without qualifiable pain will be recruited providing they have symptomatic disease as judged in the opinion of the Investigator (ie, any visible lesion or lesion affecting activities of daily living), and as far as they meet other inclusion criteria.\n   * For patients 2 years old: Symptomatic disease as judged in the opinion of the Investigator (ie, any visible lesion or lesion affecting activities of daily living), and patients will be recruited as far as they meet other inclusion criteria.\n7. Patients whose pain from vascular malformations has been stable for at least 30 days prior to screening and, if taking analgesic medication, does not require a change in the type of analgesic medication or its dosage during the screening period.\n8. Patients who agree that they or their partner (if either of them is of childbearing potential) will use appropriate contraception (eg, condom and spermicide combination, low-dose pills or other appropriate contraceptive methods, sterilization, intrauterine device) from the time of consent until 90 days after the last dose of study intervention.\n9. Patients or their LAR who are able to give age-appropriate informed consent at the time of screening.\n10. Patients who are judged by the Investigator to be able to comply with the instructions of the Investigator and the study coordinator regarding the matters specified in the protocol, such as the use of study intervention and concomitant use of prohibited drugs.\n\nExclusion Criteria:\n\n1. Patients with the following diseases: Simple telangiectatic malformation, lymphangiomatosis, lymphangiectatic malformation associated with Gorham's disease, lymphangiectasia, familial cutaneous mucocutaneous venous malformation, blue rubber ball-like nevus syndrome, M-CM\u002FMCAP, CLAPO syndrome, Proteus syndrome, Parkes Weber syndrome, Sturge-Weber syndrome, Mafucci syndrome, Osler's disease, Cowden's disease, or Adams-Oliver syndrome.\n2. Patients with uncontrolled diabetes mellitus (HbA1c ≥ 7.0%) or diseases with abnormal glucose metabolism (glycogenic diseases, galactosemia, primary lactose intolerance, etc).\n3. Patients with ischemic heart disease, arrhythmia, or heart failure (NYHA III or IV).\n4. Patients with gastrointestinal disorders that affect drug absorption, as determined by the Investigator.\n5. Patients with concomitant or pre-existing serious drug hypersensitivity to PI3Kα inhibitors.\n6. Patients with allergy history of grade ≥ 3 and\u002For history of grade ≥ 3 allergic reactions to drug.\n7. Patients with known hypersensitivity to quinine.\n8. Patients with concomitant or pre-existing alcohol or drug abuse.\n9. Patients with ANC of \\\u003C1.5×10\\^9\u002FL.\n10. Patients with acute or chronic kidney disease and\u002For dialysis dependence. Patients with screening eGFR \\\u003C30 mL\u002Fmin\u002F1.73m\\^2 using the beside Schwartz equation for patients aged \\\u003C18 years of age or CKD-EPI formula for \\>18 years of age will also be excluded.\n11. Patients who are judged by the Investigator to have hepatic impairment.\n12. Patients with total bilirubin ≥1.5×ULN for age (unless there is a history of Gilbert Syndrome), ALT ≥2×ULN for age, or AST ≥2×ULN for age will be excluded.\n13. Patients with target lesion infection that require treatment within 28 days prior to screening.\n14. Patients who have undergone invasive treatment, including sclerotherapy or laser therapy, for the target lesion within 84 days prior to screening.\n15. Patients who have used other PI3Kα inhibitors or sirolimus within 84 days prior to screening.\n16. Patients who have participated in other clinical studies within 90 days prior to the date of consent.\n17. Patients who have participated in a clinical study of KP-001 for any period and have received an investigational drug in the past year.\n18. Patients wearing orthodontic appliances, cochlear implants, etc, that may affect MRI, or patients in whom MRI is not feasible or, for example, patients who may have a contraindication to sedation and would require sedation in order to have MRI completed.\n19. Patients who are unable to take oral medications.\n20. Pregnant women, lactating female patients, female patients who may be pregnant, female patients who wish to become pregnant during the study period and up to 90 days after the last dose of study intervention, or male patients who have partners who wish to become pregnant.\n21. Patients with any other illness or medical condition who are judged by the Investigator to be inappropriate as patients for this study.\n22. Patients who have received or plan to receive live vaccines during the study period.","2 Years",{"count":55,"type":22},[85],"PHASE3","This is a phase 3, double-blind, randomized, placebo-controlled, parallel group, adaptive, multicenter study planned to be conducted at multiple sites in North America, Canada, Taiwan and South Korea.\n\nThe purpose of this study is to measure the efficacy and safety of KP-001 compared with placebo in patients aged ≥2 years with common VM, common LM, or KTS\u002FCLOVES syndrome.\n\nAn independent data monitoring committee (DMC) will be established to determine whether to discontinue or continue the study. It will also determine the redesign of the number of cases based on the result of the interim analysis.\n\nThe study will comprise the following:\n\n* Screening Period: Up to 42 days prior to the first dose of study intervention.\n* Treatment Period 1: This is a double-blind period in which KP-001 100 mg (or lower dose depending on their body weight) or placebo will be administered to patients once daily after breakfast until Week 24.\n* Treatment Period 2: After 24 weeks of double blind treatment, all patients will switch to the KP-001 open label extension and treated up to Week 52.\n* Follow-up Visit: This visit will occur 30 days after the last dose of study intervention, and assessments will be performed per the SoA.\n* Discontinuation Visit: Patients who discontinue study intervention will be requested to continue participating in the study and assessments will be performed per the SoA. If the patients request to withdraw from the study, all tests and evaluations when possible will be performed at Discontinuation visit.",[29,88,89,90],"Lymphatic Malformations","Klippel-Trenaunay Syndrome","CLOVES Syndrome","2025-12-18",{"date":93,"type":38},"2025-12-19",{"date":95,"type":22},"2026-02-26",{"date":97,"type":22},"2028-02",{"name":99,"class":100},"Kaken Pharmaceutical","INDUSTRY",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":111,"phases":4,"briefSummary":112,"conditions":113,"keywords":117,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100592502","diagnostic-imaging-of-vascular-malformations-using-msot-and-ulm-100592502","NCT06994260","Diagnostic Imaging of Vascular Malformations Using MSOT and ULM","Multispectral Optoacoustic Tomography (MSOT) and Ultrasound Localization Microscopy (ULM) as Diagnostic Imaging for Lymphatic, Venous and Arteriovenous Malformations","Inclusion Criteria:\n\n* Confirmed vascular malformations (arteriovenous, venous, or lymphatic).\n* ≥18 years old and able to give their consent\n\nExclusion Criteria:\n\n* No imaging for diagnostic confirmation has been performed or is planned.\n* Lack of written consent\n* \\\u003C18 years old\n* Safety concerns of the study physician (a patient with physical, psychological, or psychiatric conditions that, in the opinion of the study physician, could compromise the patient's safety or the quality of the data, thereby making the patient an unsuitable candidate for the study).","18 Years",{"count":110,"type":22},15,"OBSERVATIONAL","This clinical study evaluates the efficacy and accuracy of Multispectral Optoacoustic Tomography (MSOT) and Ultrasound Localization Microscopy (ULM) for imaging and diagnosing vascular malformations (venous, arteriovenous, lymphatic). The study aims to enhance diagnostic precision and improve treatment planning through advanced non-invasive imaging techniques.",[114,115,116,29],"Vascular Malformation","Arteriovenous Malformation","Lymphatic Malformation",[114,118,115,116,119,120],"Venous Malformation","MSOT","ULM","2025-06-20",{"date":123,"type":38},"2025-06-22",{"date":125,"type":22},"2025-08-01",{"date":127,"type":22},"2026-06-01",{"name":129,"class":45},"University Hospital Erlangen",1]