[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Maxima Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":255},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,45,81,126,155,182,208,231],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100597659","the-use-of-the-bambi-belt-in-exteremly-preterm-infants-an-implementation-study-100597659",false,"NCT07061366","The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study.","The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study","BB-EP","Inclusion Criteria: Preterm born \\\u003C26 weeks; first week of life -\n\nExclusion Criteria: skin integrity problems prior to study, palliative care.\n\n\\-","ALL","1 Week",{"count":20,"type":21},15,"ESTIMATED","1 Month","OBSERVATIONAL","This observational, non-interventional cohort study evaluates the clinical use of the Bambi Belt-a CE-certified, wireless device for non-invasive heart rate and respiration monitoring-in extremely preterm infants (\\\u003C26 weeks gestation). 15 infants with intact skin and age \\\u003C24 hours will be monitored using the Bambi Belt during the first ten days of life. Primary outcomes include ease of use (application, signal stability), skin tolerance, and user experience (nurses and parents). Standard care remains unchanged. Data will be collected via clinical records and evaluation forms.",[26,27],"Preterm","Monitoring",[29,30,31],"wireless","monitoring","heart rate","RECRUITING","2026-03-09",{"date":35,"type":36},"2026-03-11","ACTUAL",{"date":38,"type":36},"2025-08-10",{"date":40,"type":21},"2027-01-01",{"name":42,"class":43},"Maxima Medical Center","OTHER",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":68,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100625403","placeus-feasibility-study-of-contrast-enhanced-ultrasound-to-visualize-maternal-uterine-spiral-arteries-postpartum-100625403","NCT07422181","PlaCEUS: Feasibility Study of Contrast-enhanced Ultrasound to Visualize Maternal Uterine Spiral Arteries Postpartum.","PlaCEUS","Inclusion Criteria:\n\n* Pregnant patient at a minimum age of 18 years\n* Singleton pregnancy at term (≥37 weeks gestation)\n* Planning to deliver at the Máxima Medical Centre\n* Able to provide informed consent\n* Intravenous access present at the time of delivery\n\nExclusion Criteria:\n\n* Multiple gestation pregnancy\n* Contra-indications to CEUS, e.g. known allergy for constituents of SonoVue™\n* Planning on breastfeeding\n* Medical emergency during or after delivery, which makes CEUS impossible or undesirable\n* No intravenous access present at the time of delivery\n* Body Mass Index \\>40 kg\u002Fm2.\n* Pre-eclampsia requiring medication\n* Foetal growth restriction \\\u003C p3","FEMALE","18 Years",{"count":55,"type":21},5,"INTERVENTIONAL",[58],"NA","During pregnancy, unique blood vessels form within the uterine wall, known as spiral arteries. These vessels originate from the uterine artery, which is the main artery supplying blood to the uterus. Throughout pregnancy, spiral arteries undergo significant changes to increase blood and oxygen flow to the placenta, ensuring the developing baby receives adequate nutrients. When these arteries fail to remodel properly, complications such as pre-eclampsia or fetal growth restriction can occur.\n\nUntil now, direct observation and evaluation of spiral arteries during pregnancy has not been feasible. Contrast-enhanced ultrasound may provide a breakthrough in this area. In this study, the investigators aim to use this imaging technique to visualize spiral arteries after the placenta has been delivered. If successful, this could allow to assess their structural quality. Additionally, the investigators will employ ultrasound to monitor physiological changes in the uterine artery during late pregnancy (after 37 weeks), during labour, and postpartum.\n\nBy conducting these measurements, the investigators hope to develop methods for detecting spiral artery abnormalities earlier in pregnancy. Early identification could enable timely interventions and help prevent severe complications.",[61,62,63,64,65,66,67],"Spiral Arteries","Uterine Artery Hemodynamics","Contrast Enhanced Ultrasound","Doppler Parameters","Resistance Index","Pulsatility Index","Systolic\u002FDiastolic Ratio",[69,70,71],"Spiral arteries","Uterine artery hemodynamics","contrast enchanced ultrasound","2026-02-12",{"date":74,"type":36},"2026-02-19",{"date":76,"type":36},"2025-12-17",{"date":78,"type":21},"2026-07-01",{"name":42,"class":43},1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":56,"phases":92,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":80},"100582120","feasibility-of-remote-ectg-monitoring-homehospital-in-complicated-pregnancies-100582120","NCT06859177","Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies","Remote Electrophysiological Cardiotocography (eCTG), Evaluation of Feasibility in (a Selected Group of) Complicated Pregnancies From 32 Until 37 Weeks Gestational Age in a Home@Hospital Setting: a Prospective Cohort Study","HASTA","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Minimum age of 18 years old\n* Pregnant patients with a gestational age between 32+0 and 36+6 weeks and days\n* Singleton pregnancy\n* Any indication for fetal monitoring at least twice per week (e.g.):\n\n  * Pre-eclampsia (PE)\n  * Fetal growth restriction (FGR)\n  * Preterm pre-labor rupture of membranes (PPROM)\n* Absence of exclusion criteria \\> 24 hours after admission.\n* Oral and written informed consent is obtained.\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* An indication for intravenous medication\n* Blood pressure \\>160\u002F110 A millimeter of mercury (mmHg)\n* Absent-\u002For reversed flow umbilical artery Doppler\n* Hemolysis Elevated Liver enzymes and Low Platelets (HELLP) (Table 1)\n* Obstetric intervention expected \\\u003C48 hours, e.g. due to:\n\n  * Non reassuring cardiotocography (CTG)\n  * Active vaginal blood loss\n  * Signs of abruption placentae\n  * Meconium stained amniotic fluid\n  * Signs of chorioamnionitis\n* Patients admitted with a clinical diagnosis of sepsis with hypotension (i.e. septic shock).\n* Insufficient knowledge of Dutch or English language\n* Insufficient comprehension of instruction Nemo Remote® or patient information\n* Fetal and\u002For maternal cardiac arrhythmias\n* Contraindications to abdominal patch placement (dermatologic diseases of the abdomen precluding preparation of the abdomen with abrasive paper)\n* Patients connected to an external or implanted electrical stimulator, such as Transcutaneous Electro Neuro Stimulation (TENS) and pacemaker (because of disturbance of the electrophysiological signal).",true,{"count":91,"type":21},60,[58],"The objective of this single center, interventional cohort study is to evaluate the feasibility of remote electrophysiological cardiotocography (eCTG) monitoring in complicated pregnancies in a home@hospital setting.\n\nThe primary objective is to assess:\n\n• The success rate of the self-administered eCTG measurement\n\nThe secondary objective is to asses:\n\n* Maternal and perinatal outcomes\n* Patients wellbeing and satisfaction.\n* Healthcare professionals' (HCPs') satisfaction\n* Analysis of antenatal costs\n\nParticipants will:\n\n* Self-administer remote eCTG monitoring once daily during admission (or at least twice weekly at the outpatient clinic)\n* Self-measure their blood pressure, heartrate and temperature\n* Enter the measurements, symptoms and worries into an application on their telephone.\n* Answer questionnaires at 3 moments during the study, assessing their wellbeing and satisfaction of the received care and self-administered remote monitoring device.",[95,96,97],"Pregnancy Related","Remote Monitoring","Feasibility",[99,100,101,102,103,104,105,106,107,30,108,109,110,111,112,113,114,115,116,117],"feasibility","remote","complicated pregnancies","antenatal","Non invasive fetal electrocardiography (NI-fECG)","electrophysiological cardiotocography (eCTG)","high-risk pregnancies","pregnancy","maternal and fetal monitoring","electrophysiological","non invasive","preterm pre-labor rupture of membranes (PPROM)","pre-eclampsia (PE)","fetal growth restriction (FGR)","home monitoring","remote monitoring","second trimester","self-administered","satisfaction","2025-09-23",{"date":120,"type":36},"2025-09-26",{"date":122,"type":36},"2025-03-25",{"date":124,"type":21},"2026-12",{"name":42,"class":43},{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":89,"sex":52,"minAge":134,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":44},"100604637","amniotic-fluid--the-preterm-gut-100604637","NCT07152106","Amniotic Fluid & the Preterm Gut","The Impact of Amniotic Fluid on the Development and Microbial Colonization of the Preterm Intestinal Tract: the AMFIBIE Study","AMFIBIE","Inclusion Criteria:\n\n* Maternal age ≥16 years\n* Written informed consent\n* Successful collection of amniotic fluid\n\nExclusion Criteria:\n\n* Pregnancies complicated by fetal congenital and\u002For chromosomal abnormalities.\n* Insufficient proficiency of Dutch or English language","16 Years",{"count":136,"type":21},275,"Background:\n\nNecrotizing enterocolitis (NEC) and sepsis in preterm infants have been linked to intestinal immaturity and preclinical gut microbiota alterations. An important yet understudied contributor in the development of the gastrointestinal tract (GIT) is amniotic fluid (AF). Knowledge is lacking on the critical shifts that may occur in AF in extremely preterm birth. The aim of the current study is to assess the composition of AF using advanced biomedical techniques. Secondary objectives are to assess AF profiles of infants with chorioamnionitis (CAM) and\u002For fetal growth restriction (FGR), assess key metabolites across gestation, correlate AF profiles with neonatal outcomes, and explore associations with early gut microbiota.\n\nMethods:\n\nln this multicenter, prospective, cohort study, AF (\\~5 mL) will be collected from obstetric patients delivering their infants extremely preterm (gestational age (GA) 24+0\u002F7-27+6\u002F7 weeks, n=125), either during vaginal delivery or cesarean section (CS). Additionally, AF samples will be collected from a reference group (n=150), including early midtrimester (GA \\\u003C23+\u002F7 weeks), very early and moderate to late preterm (GA 28+0\u002F6-36+6\u002F7 weeks), and full-term pregnancies (GA 37+0\u002F7-41+6\u002F7 weeks). Thorough characterization of AF will be conducted, including microbial profiling and metabolomics. Microbiota profiling of neonatal fecal samples will be conducted to assess the association between AF and early neonatal gut colonization patterns.\n\nDiscussion and expected results:\n\nAF profiles associated with CAM and\u002For FGR in extremely preterm infants are expected to be identified, as well as relevant associations with neonatal health outcomes (including NEC and sepsis) and early neonatal gut colonization patterns. The current study will not only increase the understanding of the GIT development and the pathogenesis of NEC and sepsis but may also aid in the identification of high-risk infants. In the future, these findings may facilitate early targeted microbiota-based interventions to prevent disease progression and ultimately improve clinical outcomes.",[139,140,141,142,143,144,145,146],"Chorioamnionitis","Chorioamnionitis Affecting Fetus or Newborn","Necrotizing Enterocolitis of Newborn","Neonatal Sepsis, Early-Onset","Neonatal Sepsis, Late-Onset","Fetal Growth Restriction (FGR)","Preterm Birth Complication","Prematurity Complications","2025-08-28",{"date":149,"type":36},"2025-09-03",{"date":151,"type":36},"2024-10-14",{"date":153,"type":21},"2027-10-14",{"name":42,"class":43},{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":89,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":56,"phases":164,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":173,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":4},"100598870","feasibility-study-continuous-fetal-monitoring-during-maternal-exercise-100598870","NCT07077109","Feasibility Study: Continuous Fetal Monitoring During Maternal Exercise","Continuous Non-invasive Electrophysiological Monitoring During Maternal Exercise: a Feasibility Study","NIEM-S","Inclusion Criteria:\n\n* Minimal age of 18 years old\n* Pregnant women with an uncomplicated singleton pregnancy and a gestational age between 30+0 and 40+0 weeks and days\n* Oral and written informed consent is obtained\n* Engage in aerobic exercise during pregnancy\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Insufficient knowledge of Dutch or English language\n* Women with a multiple pregnancy\n* Contra-indications for the Nemo Fetal Monitoring System (NFMS):\n\n  * Fetal and\u002For maternal cardiac arrhythmias\n  * Contraindications to abdominal placement (dermatologic diseases of the abdomen precluding preparation of the abdomen with abrasive paper)\n  * Women connected to an external or implanted electrical stimulator, such as a pacemaker (because of disturbance of the electrophysiological signal)\n* Fetus with known congenital or chromosomal abnormalities\n* Women with absolute or relative contraindications to aerobic exercise during pregnancy at time of inclusions and during maternal exercise:\n\n  * Mild or severe respiratory diseases (e.g. chronic obstructive pulmonary disease, restrictive lung disease and cystic fibrosis)\n  * Mild or severe acquired or congenital heart disease with exercise intolerance\n  * Uncontrolled or severe arrhythmia\n  * Vasa previa\n  * Type 1 diabetes\n  * IUGR\n  * Severe PE\n  * Cervical insufficiency\n* Women with relative contraindications to aerobic exercise during pregnancy:\n\n  * Mild respiratory disorders\n  * Mild congenital or acquired heart disease\n  * Well-controlled type 1 diabetes\n  * Pre-eclampsia\n  * Cervical insufficiency\n  * Placenta previa\n  * Untreated thyroid disease\n  * Symptomatic, severe eating disorder\n  * Multiple nutrient deficiencies and\u002For chronic undernutrition\n  * Moderate-heavy smoking (\\> 20 cigarettes per day)",{"count":20,"type":21},[58],"This feasibility study will be the first study to assess the feasibility of continuous electrophysiological monitoring during maternal exercise in women with an uncomplicated pregnancy. This may help to better understand fetal condition during exercise and offer personalised exercise recommendations in the future. In future, validating the feasibility and safety of exercise could promote greater exercise engagement among pregnant women and increase fetal wellbeiing.",[167,27],"Pregnancy",[169,167,170,171,172],"Electrophysiological monitoring","Sport","Feasibility study","Maternal exercise","NOT_YET_RECRUITING","2025-07-23",{"date":176,"type":36},"2025-07-28",{"date":178,"type":21},"2025-10-15",{"date":180,"type":21},"2026-03-13",{"name":42,"class":43},{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":134,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":56,"phases":191,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":80},"100520200","optimal-postoperative-chest-tube-and-pain-management-in-patients-surgically-treated-for-primary-spontaneous-pneumothorax-pneumotrial-100520200","NCT06053476","Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial)","Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial); a Randomized Controlled Trial","Inclusion Criteria:\n\n* All patients operated for PSP\n* Age ≥ 16 years\n* Able to read and understand the Dutch language\n* Mentally able to provide informed consent\n* Patients should have a preoperative chest CT scan in order to exclude evident secondary pneumothorax. Previously made CT scans, within a time range of maximum 5 years, are accepted. The identification of blebs or bullae on CT scan is not defined as secondary pneumothorax.\n\nExclusion Criteria:\n\n* Previous ipsilateral thoracic surgery (except diagnostic thoracoscopy only) or ipsilateral thoracic radiotherapy\n* Underlying lung disease that provoked the pneumothorax (secondary pneumothorax): genetically proven Birt-Hogg-Dubé syndrome, periodic pneumothorax in female patients in reproductive age with known endometriosis (or known catamenial pneumothorax), pulmonary cystic fibrosis, active pneumonia, lung fibrosis, chronic obstructive pulmonary disease (COPD), pulmonary ipsilateral malignancy\n* Contra-indications for TEA (infection at skin site, increased intracranial pressure, non-correctable coagulopathy, sepsis and mechanical spine obstruction)\n* Patients chronically (\\>3 months) using opioids will be excluded since postoperative baseline opioid requirement will be higher and TEA remains the preferred technique for these patients\n* Allergic reactions to analgesics used in the study",{"count":190,"type":21},366,[58],"Guidelines lack high quality evidence on optimal postoperative chest tube and pain management after surgery for primary spontaneous pneumothorax (PSP). This results in great variability in postoperative care and length of hospital stay (LOS). Chest tube and pain management are prominent factors regarding enhanced recovery after thoracic surgery, and in standardised care they are crucial to improve quality of recovery and decrease LOS.\n\nHistorically, postoperative chest tubes are left in place for at least a fixed number of 3-5 days, irrespective of absence of air leakage. This period was deemed necessary for adequate pleurodesis and prevention of recurrence. However, it is suggested that removal on the same day of surgery is safe and associated with a reduced LOS.\n\nRegarding postoperative pain management, thoracic epidural analgesia (TEA) is the gold standard for postoperative pain management following video-assisted thoracic surgery (VATS). Although the analgesic effect of TEA is clear, it is associated with hypotension and urinary retention. Therefore, unilateral regional techniques, such as paravertebral blockade (PVB), are developed.\n\nThe investigators hypothesize that early chest tube removal accompanied by a single-shot paravertebral blockade (PVB) for analgesia is safe regarding pneumothorax recurrence and non-inferior regarding pain, but superior regarding LOS when compared to standard conservative treatment.",[194,195,196,197,198,199],"Pneumothorax, Primary Spontaneous","VATS","Pain, Postoperative","Locoregional Anaesthesia","Thoracic Epidural","Chest Tube Drainage","2025-05-06",{"date":202,"type":36},"2025-05-09",{"date":204,"type":36},"2023-11-08",{"date":206,"type":21},"2028-11-01",{"name":42,"class":43},{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":89,"sex":17,"minAge":53,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":56,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":80},"100581452","ketogenic-diet-prior-to-bariatric-surgery-100581452","NCT06850493","Ketogenic Diet Prior to Bariatric Surgery","The Impact of a Preoperative Very Low Calorie Ketogenic Diet (VLCKD) on Body Composition in Patients Undergoing Bariatric Surgery: a Randomised Controlled Trial","Inclusion Criteria:\n\n* Eligible for bariatric surgery (≥35 kg\u002Fm2 with obesity-related comorbidities, or a BMI of\n\n  * 40 kg\u002Fm2 with or without comorbidities)\n* Roux-en-Y Gastric bypass (RYGB)\n\nExclusion Criteria:\n\n* Weighing over 150kg because this amount is a limitation by the DXA device\n* Diabetes mellitus type 1\n* Allergic to milk proteins\n* A recent history of a heart attack (\\\u003C 12 months), heart failure or cardiac arrhythmias\n* Kidney and\u002For liver failure (creatinine levels \\>1.3 mg\u002Fdl or liver enzyme levels (AST, ALT, GGT)) less than three times over the upper normal threshold\n* Current infectious, sepsis or malignant disease\n* Rare condition like galactosemia, phenylketonuria or porphyria\n* Persistent diarrhoea\n* Hypokalaemia, chronic therapies with diuretics as furosemide and hydrochlorothiazide\n* Pregnancy or plans to get pregnant in the coming months\n* Patients who did not meet criteria to be eligible for bariatric surgery (BMI \\\u003C35, psychological or unstable psychiatric disorders, inadequate dietary regimen or inadequate exercise pattern which can't be resolved in the upcoming 6 months)","65 Years",{"count":217,"type":21},46,[58],"Standard dietary regiments for bariatric are advised prior to surgery. The most used diet is a very low calorie diet (VLCD). These diets potentially have multiple pittfalls.\n\nVery low-calorie ketogenic diets (VLCKD) have been proposed as a new regimen for achieving weight- and liver volume loss in patients undergoing bariatric surgery. The beneficial effect of VLCKDs compared to (V)LCDs is the aimed preservation of FFM and RMR, while still reducing FM. Only a few small studies addressed the role of VLCKDs prior to bariatric surgery, and the data including FFM and FM is actually scarce. Therefore, a well-designed randomised controlled trial is necessary to establish the efficacy of a VLCKD.",[221,222],"Bariatric Surgery Candidate","Ketogenic Dieting","2025-02-24",{"date":225,"type":36},"2025-02-27",{"date":227,"type":36},"2022-09-01",{"date":229,"type":21},"2025-12",{"name":42,"class":43},{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":89,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":240,"conditions":241,"keywords":244,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":80},"100524069","prospective-registration-of-the-performance-of-the-iota-adnex-model-in-dutch-gynaecological-practice-100524069","NCT06103916","Prospective RegIstration Of the peRformance of the IoTa ADNEX Model in Dutch gYnaecological Practice","PRIORITY","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Presence of a complex ovarian tumor\n3. Ultrasound assessment in accordance with IOTA definitions and application of the ADNEX model\n4. Understanding of Dutch language\n\nExclusion Criteria:\n\n1. Women with an ovarian tumor that meets the IOTA criteria of a benign easy descriptor:\n\n   1. Unilocular tumor with ground glass echogenicity in premenopausal woman suggestive of endometrioma\n   2. Unilocular tumor with mixed echogenicity and acoustic shadows in premenopausal women (suggestive of benign cystic teratoma)\n   3. Unilocular tumor with regular walls and maximal diameter \\\u003C 10cm (suggestive of simple cyst or cystadenoma)\n   4. Remaining unilocular tumors with regular walls\n2. Histologically proven malignancy prior to ultrasound",{"count":239,"type":21},613,"Multicenter prospective cohort study in which patients ≥18 years with an ovarian tumor for which an ultrasound has been performed in accordance with IOTA criteria and the IOTA ADNEX model has been applied are included. Ultrasound data from these patients will be prospectively recorded in a database to determine the diagnostic accuracy of the IOTA ADNEX model in Dutch gynaecological practice.",[242,243],"Ovarian Tumor","Ovarian Cancer",[245,246],"ultrasound","ADNEX model","2023-10-25",{"date":249,"type":36},"2023-10-27",{"date":251,"type":36},"2022-07-15",{"date":253,"type":21},"2028-05",{"name":42,"class":43},""]