279. 巨大静脈奇形(頚部口腔咽頭びまん性病変) Huge venous malformation with cervical, oral and pharyngeal diffuse lesion Clinical trials / Disease details


臨床試験数 : 15 薬物数 : 24 - (DrugBank : 10) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 105

  
6 trials found
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1JPRN-jRCT2051200046
15/01/202125/08/2020A study for evaluation of efficacy and safety of ethanolamine oleate in patients with venous malformationsEvaluation of efficacy and safety of ethanolamine oleate in sclerotherapy in patients with venous malformations: A multicenter, open-label, single-arm study - EO-1 Venous malformation difficult to removeInjection of 5% ethanolamine oleate which is double diluted by contrast or normal saline for the venous malformation, within maximum dosage of 0.4 mL/kg. Same method of administration is performed for children. Maximum volume of the drug in once treatment is 30 mL after preparation.Nomura TadashiNomura Tadashi;Ozaki MineRecruitingNot applicableNot applicableBoth44Phase 3Japan
2NCT04930952
(ClinicalTrials.gov)
February 28, 201911/6/2021Complications of Ethanol-amine Oleate Intralesional SclerotherapyComplications of Ethanol-amine Oleate Intralesional Sclerotherapy Injections of Maxillofacial Venous Malformations in Pediatric PatientsVenous MalformationDrug: Ethanol-amine Oleate Sclerotherapy InjectionSuez Canal UniversityNULLCompletedN/A12 YearsAll15Egypt
3ChiCTR-OIB-15007455
2015-03-182015-11-24Effect of sclerotherapy on venous malformation associated with localized intravascular coagulopathy: A prospective, before-after controlled studyEffect of sclerotherapy on venous malformation associated with localized intravascular coagulopathy: A prospective, before-after controlled study venous malformation1:sclerotherapy with ethanol;Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of MedicineNULLRecruitingBoth1:40;I (Phase 1 study)China
4JPRN-jRCTs071180067
23/10/200920/03/2019Clinical research of intralesional sclerotherapy in the oral and maxillofacial regionClinical research for safty and efficacy in intralesional sclerotherapy with ethanolamine oleate for subcutaneous venous malformation in the oral and maxillofacial region - EOST-OMS Venous malformation in the oral and maxillofacial region
Sclerotherapy, Venous malformation, ethanolamine oleate;angioma, venous
Single arm study, open (masking not used), no assignment
All procedures will be done with oral surgeon and radiologist in angiography room. (For superficial lesion, procedures will be done with intermittent simple X-ray for reduction of exposure, despite using angiography to confirm drainage veins in oral and maxillofacial outpatient clinic.)
1. Local anesthesia into the lesion.
2. Puncture with 22-24G needle and confirm the backflow of blood.
3. Stabilize the needle and check the distribution and blood flow of the lesion by angiography and computed tomography (CT) with contrast medium. If there is any risk that sclerosing agent will escape whole body, we must decide the cancellation of the trial. If we can block the drainage vein over 5 minutes, we decide that the trial can continue. (For superficial lesions, we inject contrast medium in oral and maxillofacial outpatient clinic and confirm retention of contrast medium using intermittent simple X-ray.)
4. Treat with injection 5% ethanolamine oleate(EO) (diluted by Iopamiron 300) . Volume of the 5%EO will be decided by situation, but the maximum volume is 20ml (5% EO) by one treatment. After 5 minites, the 5%EO collect as possible.
5. Check the hemostasis of the injection point(s).
Danjo AtsushiNULLRecruitingNot applicableNot applicableBoth25Phase 2Japan
5EUCTR2009-011276-29-FR
(EUCTR)
21/08/200915/05/2009Systemic and local diffusion of ethanol after administration of ethanol 96% formulated in a gel (L0122 Gel) and ethanol 98% solution (absolute ethanol) by the percutaneous route, in patients with congenital venous malformations (CVM): pharmacokinetic, pharmacodynamic and clinical study.Systemic and local diffusion of ethanol after administration of ethanol 96% formulated in a gel (L0122 Gel) and ethanol 98% solution (absolute ethanol) by the percutaneous route, in patients with congenital venous malformations (CVM): pharmacokinetic, pharmacodynamic and clinical study. patients with congenital venous malformations (CVM)Product Name: Ethanol gel
Product Code: L0122
Other descriptive name: ETHANOL (96 PER CENT)
Trade Name: Dehydrated Alcohol (Absolute Alcohol) BP for Injection
Product Name: Dehydrated Alcohol (Absolute Alcohol) BP for Injection
Other descriptive name: ETHANOL BP
ORFAGENNULLNot RecruitingFemale: yes
Male: yes
24Phase 2France
6NCT00462462
(ClinicalTrials.gov)
May 200716/4/2007Systemic and Local Diffusion of Ethanol After Administration of Ethanol 96% Formulated in a Gel and Ethanol 98% Solution by the Percutaneous Route, in Patients With Congenital Venous Malformations:Pharmacokinetic, Pharmacodynamic and Clinical Study.Systemic and Local Diffusion of Ethanol After Administration of Ethanol 96% Formulated in a Gel and Ethanol 98% Solution by the Percutaneous Route, in Patients With Congenital Venous Malformations:Pharmacokinetic, Pharmacodynamic and Clinical Study.Congenital Venous MalformationDrug: Ethanol 96% Gel;Drug: Ethanol 98% SolutionOrfagenFDA Office of Orphan Products DevelopmentCompleted12 YearsN/AAll32Phase 2United States;France