[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"robotic-surgical-procedure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:robotic-surgical-procedure":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":35,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100604083","phase-4-assessing-the-efficacy-of-indocyanine-green-for-ureter-identification-during-robot-assisted-surgery-in-advanced-stage-endometriosis-100604083",false,"NCT07144904","Assessing the Efficacy of Indocyanine Green for Ureter Identification During Robot-Assisted Surgery in Advanced-Stage Endometriosis","A Side-Randomized, Self-Controlled Trial Assessing the Efficacy of Indocyanine Green Fluorescence Imaging for Intraoperative Ureter Identification During Robot-Assisted Single-Site Surgery in Advanced-Stage Endometriosis","Inclusion Criteria:\n\n* Stage III or IV endometriosis (rASRM classification)\n* Planned robotic transabdominal endometriosis excision with or without hysterectomy.\n\nExclusion Criteria:\n\n\\- Subjects who are part of a vulnerable population will be excluded including those who are prisoners, younger than 18 years old, pregnant, individuals with mental disabilities or cognitive impairment.","FEMALE","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The goal of this side-randomized, self-controlled trial, 1-site study is to explore the efficacy of Indocyanine Green Fluorescence (ICG) for Intraoperative Ureter Identification During Robot-Assisted Single-Site Surgery in Advanced-Stage Endometriosis.\n\nResearchers will perform temporary ureteral stent using indocyanine green fluorescence for intraoperative ureteral identification on either the left or right side of subjects who are undergoing a robotic assisted transumbilical resection of advanced endometriosis.\n\nParticipants will be randomized to receive ICG-assisted ureteral identification on either the left or right side. Randomization will be conducted using a computer-generated block randomization method.\n\nThe primary aim is to determine whether ICG-assisted ureter visualization can reduce operative time for endometriosis resection and ureterolysis, and minimize the risk of ureteral injury.\n\nSecondary objectives are to assess the feasibility and safety of temporary ureteral ICG stenting for intraoperative ureter identification in advanced endometriosis.",[26,27,28,29,30,31,32,33,34],"Indocyanine Green (ICG)","Robotic Surgical Procedure","Deep Infiltrating Endometriosis (DIE)","Endometriosis Pelvic","Endometriosis (Diagnosis)","Endometriosis of the Cul-de-sac","Ureteral Stent Placement","Ureteral Injury","Endometriosis Ovaries",[36,37,38,39,40],"ureteral stent placement","indocyanine green","endometriosis","robotic surgery","ureteral identification","NOT_YET_RECRUITING","2025-08-20",{"date":44,"type":45},"2025-08-28","ACTUAL",{"date":47,"type":20},"2025-10-01",{"date":49,"type":20},"2026-03-15",{"name":51,"class":52},"Baylor College of Medicine","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":21,"phases":64,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100585850","fetoscopic-robotic-open-spina-bifida-treatment-100585850","NCT06907732","Fetoscopic Robotic Open Spina Bifida Treatment","Fetoscopic Robotic Open Spina Bifida Treatment - a Pilot Feasibility Study","FROST","Inclusion Criteria:\n\n* Isolated open fetal spina bifida\n* Healthy pregnant patient without risk factors for preterm delivery\n* Candidate for open fetal spina bifida surgery.\n* Maternal age 18 years or more and able to consent\n* Provision of written informed consent to participate in this study\n* Gestational age allowing for fetal surgery prior to 26 weeks gestation.\n\nExclusion Criteria:\n\n* Contraindication for surgery or safe anesthesia due to a severe maternal medical condition, including morbid obesity (BMI \\>40 kg\u002Fm2)\n* History of preterm birth, short cervical length, cervical cerclage\n* Placenta or vasa previa, invasive placentation\n* Inaccessibility of the uterus due to severe maternal obesity, uterine fibroids, bowel or placental superposition\n* Major fetal structural or genetic anomalies unrelated to spina bifida, requiring surgery or potentially leading to infant death or severe handicap\n* Neural tube defects other than open spina bifida\n* Absence of Chiari II malformation on ultrasound or MRI\n* Severe fetal kyphosis (\\>30 degrees)\n* Upper lesion level lower than sacral vertebra S1.\n* Multiple gestation\n* Fetal bleeding disorder (eg. Fetal\u002Fneonatal allo-immune thrombocytopenia)\n* Maternal infectious disorder which could result in materno-fetal transmission (eg HIV with high viral load)",{"count":63,"type":20},15,[65],"NA","Fetal spina bifida is a common birth defect that results in hydrocephalus, motor-, bowel-, bladder- and sexual dysfunction in the child. The condition is progressive in utero. Fetal surgery between 22-26 weeks gestation has been shown to stop the gradual fetal deterioration observed in this disease and improve infant outcomes. Children with spina bifida who have undergone fetal surgery have a lower need for hydrocephalus treatment (80%-\\>40%) and twice the chance to walk independently by the age of 3 years (20%-\\>40%). These benefits are also sustained in the longer term.\n\nThe traditional 'open' fetal surgical approach, however, as currently offered clinically at the Ontario Fetal Centre, comes with significant risks: it increases the risk of preterm birth, carries significant maternal morbidity and results in important uterine scarring. The latter comes with a risk of uterine rupture and fetal death both in the index pregnancy and future pregnancies.\n\nTo overcome these down sides of open fetal surgery, different centers have attempted a fetoscopic approach to the surgery. Fetoscopy indeed avoids uterine scarring and is likely protective against uterine rupture but is technically complex. This results in long surgical learning curves, poor dissemination of the surgery amongst centers worldwide, longer procedures and suboptimal surgical results which translate in decreased infant benefits - particularly with regards to motor function.\n\nThe investigators have developed a fetoscopic robotic approach where they leverage the dexterity of robotic instruments to perform these complex surgeries. The team expects that this will result in easier and faster procedures with better surgical outcomes and therefore fetal benefits comparable to open fetal surgery, while at the same time avoiding the need for hysterotomy.\n\nIn this prospective exploratory phase 1 study, the investigators propose to assess the feasibility of such a robotic approach, as developed and trained on a high-fidelity phantom, in 15 patients. The research team will collect maternal and fetal safety and efficacity data to inform later studies.",[68,69,70,27,71,72],"Fetal Congenital Abnormalities","Fetoscopy","Fetal Surgery","Neural Tube Defect","Open Spina Bifida","2025-05-04",{"date":75,"type":45},"2025-05-07",{"date":77,"type":20},"2025-07",{"date":79,"type":20},"2027-12",{"name":81,"class":52},"Mount Sinai Hospital, Canada"]