[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"uterine-corpus-smooth-muscle-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:uterine-corpus-smooth-muscle-neoplasm":28},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100560378","evaluation-of-ultrasound-guided-transuterine-vaginal-biopsy-technique-in-uterine-fibromatous-disease-100560378",false,"NCT06576362","Evaluation of Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease","Anatomopathological Evaluation of a New Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease","EFIBIA","Inclusion Criteria:\n\n1. Patients over 18 years of age consulting at the hospital who require surgical management for uterine smooth muscle tumors (fibroma or TMM).\n2. Able to give written consent\n3. Beneficiary or beneficiary of a social security scheme\n\nExclusion Criteria:\n\n1. Person in a period of exclusion from another research protocol at the time consent is signed.\n2. Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code, i.e. :\n\n   * Pregnant women, parturients and nursing mothers\n   * Persons deprived of their liberty by judicial or administrative decision\n   * Persons subject to psychiatric monitoring under articles L3112-1 and L3113-1 who are not covered by the provisions of article L1121-8.\n   * Minors\n   * Adults subject to a legal protection measure or unable to express their consent.\n3. A person who does not have a sufficient command of the French language to be able to give consent to participate in research.\n4. Any other reason which, in the opinion of the investigator, could compromise the safety of the research participant and\u002For interfere with the evaluation of the research objectives.","FEMALE","18 Years",{"count":20,"type":21},250,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this diagnostic, prospective study is to evaluate an innovative, minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy, in women aged 18 and more, and to evaluate complications relating to the the technique and its potential adverse events.\n\nParticipants presenting at hospital patients presenting a surgical indication for myomectomy or hysterectomy during the inclusion period will be offered the study.\n\nPreoperatively, women will undergo the following two examinations:\n\n1. A pelvic MRI, the characteristics of which will be analyzed by the expert women\\'s imaging team.\n2. A BVTE under general anaesthetic in the operating theatre on the day of the planned myomectomy or hysterectomy.\n\n250 women will be included in this study within a periofd of inclusion of 36 months and their participation is estimated to 7 months Total study duration is 43 months",[27,28],"Fibroid","Uterine Corpus Smooth Muscle Neoplasm",[30,31,32,33,34,35,36],"TMM","BVTE","diagnosis","Vaginal biopsy","echo-guided transuterine vaginal biopsy","myomectomy","hysterectomy","NOT_YET_RECRUITING","2024-08-28",{"date":40,"type":41},"2024-08-30","ACTUAL",{"date":43,"type":21},"2024-11-30",{"date":45,"type":21},"2028-06-30",{"name":47,"class":48},"Assistance Publique Hopitaux De Marseille","OTHER"]