[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Imperial College Healthcare NHS Trust\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":232},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,49,80,106,136,159,183,205],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100641757","using-fenfluramine-to-test-the-serotonin-deficiency-theory-of-depression-100641757",false,"NCT07651293","Using Fenfluramine to Test the Serotonin Deficiency Theory of Depression","FenDep","Inclusion Criteria for All Participants:\n\n* Aged 21 years and over.\n* Able to lie comfortably on their back for scanning.\n* Participants must agree to use one of the contraception methods listed in Appendix 1.\n* Capable of providing written informed consent and willing to comply with the requirements and restrictions listed in the consent form.\n* Able to read, comprehend, and record information written in English.\n* Able to access the internet through their own electronic device.\n\nInclusion Criteria for Participants with Major Depressive Disorder (MDD):\n\n* Major depressive episode diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as moderate to severe.\n* Scoring above 20 on the Montgomery-Åsberg Depression Rating Scale (MADRS).\n* Have never taken antidepressants, or are currently unmedicated for at least 8 weeks before signing the informed consent form.\n* Not classified as treatment-resistant.\n* Ongoing relationship with a general practitioner (GP) or other healthcare professional.\n\nInclusion Criteria for Healthy Controls:\n\n\\- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, and laboratory tests.\n\nExclusion Criteria for All Participants:\n\n* Presence of a general medical or psychiatric condition (excluding MDD in the relevant population), as revealed by a physical and psychiatric examination, which, in the opinion of the Principal Investigator (PI), would impair the safety of the participant or the scientific integrity of the study.\n* Ongoing treatment with medication that, in the opinion of the investigator, would compromise participant safety or the scientific integrity of the study, including but not limited to compounds known to interact with the serotonin 2A (5-HT2A) receptor or to have a significant effect on the synthesis and\u002For release of serotonin (5-HT).\n* Use of illicit compounds in the 3 months before consent, including but not limited to classic psychedelics, stimulants, 3,4-methylenedioxymethamphetamine (MDMA), and cannabis.\n* Unwillingness or inability to follow the procedures outlined in the protocol.\n* The participant is mentally or legally incapacitated.\n* Contraindications to blood sampling and\u002For arterial cannulation, including but not limited to peripheral vascular disease or Raynaud's phenomenon.\n* Contraindications to the administration of dl-fenfluramine include medications that have a significant effect on the synthesis and\u002For release of 5-HT.\n* Abnormal Allen's test and\u002For prolonged Prothrombin Time (PT), due to the arterial cannulation required for the positron emission tomography (PET) scans.\n* Participation in another research study involving ionising radiation exceeding 10 mSv within the last year.\n* Contraindications to magnetic resonance imaging (MRI) scans include, but are not limited to, pacemakers, recent metallic implants, foreign bodies in the eye, or other contraindications identified by a standard pre-MRI questionnaire.\n* Claustrophobia or any other condition that would render the participant incapable of undergoing MRI\u002FPET scanning.\n* Pregnancy or breastfeeding.\n\nExclusion Criterion for MDD Participants:\n\n\\- History of suicide attempts requiring hospitalisation.\n\nExclusion Criteria for Healthy Controls:\n\n* History of an Axis I psychiatric diagnosis.\n* History of a neurological or general medical illness that, in the opinion of the investigator, would compromise participant safety or the scientific integrity of the study.",true,"ALL","21 Years",{"count":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24],"NA","Clinical depression is a common and disabling condition characterised by persistent low mood and loss of interest that interferes with daily functioning. Serotonin is a key brain neurotransmitter involved in mood regulation, and a leading theory proposes that depression is associated with impaired serotonin function (the serotonin deficiency hypothesis), which underpins the use of selective serotonin reuptake inhibitors (SSRIs) as first-line antidepressant treatments. However, the strength and specificity of the link between serotonin dysfunction and depressive symptoms in humans remains uncertain and requires direct evidence in living human brains.\n\nPositron Emission Tomography (PET) allows in vivo quantification of neurotransmitter receptor systems using a radioactive tracer that binds to specific brain targets. The serotonin 2A receptor (5-HT2A) agonist tracer \\[11C\\]Cimbi-36 enables measurement of the active-state 5-HT2A receptor, which is highly expressed in cortical regions implicated in mood regulation. When combined with a pharmacological challenge that acutely increases serotonin levels, changes in \\[11C\\]Cimbi-36 binding can be used to estimate serotonin release capacity across different brain regions.\n\nPrevious work using an amphetamine challenge with \\[11C\\]Cimbi-36 has shown reduced serotonin release capacity in the frontal cortex of patients with depression compared with healthy controls, providing preliminary support for the serotonin deficiency hypothesis. However, amphetamine releases multiple neurotransmitters in addition to serotonin, limiting the ability to attribute these effects specifically to serotonergic dysfunction. Dl-fenfluramine is a more selective serotonin-releasing agent and therefore offers a targeted approach to probe serotonin release in the human brain.\n\nThis case-control observational study will compare serotonin release capacity between unmedicated adults with Major Depressive Disorder (MDD) and healthy control participants using dl-fenfluramine challenge combined with \\[11C\\]Cimbi-36 PET imaging. The primary objective is to test whether individuals with MDD show reduced fenfluramine-induced serotonin release, indexed by changes in \\[11C\\]Cimbi-36 binding, relative to healthy controls. Secondary objectives include exploring how multimodal imaging, blood biomarkers, and behavioural measures relate to serotonin release capacity and depressive symptom severity.\n\nFollowing completion of imaging, participants with MDD who will start SSRI treatment as part of their usual clinical care will be followed for 8 weeks with remote assessments. The study will examine whether baseline measures of serotonin release capacity predict subsequent clinical response to SSRIs, defined primarily by change in clinician-rated depression scores over the treatment period. Together, these data aim to provide a more precise test of the serotonin deficiency hypothesis of depression and to identify potential biomarkers of SSRI treatment response in MDD.",[27],"Depression - Major Depressive Disorder",[29,30,31,32,33,34,35],"Major Depressive Disorder","Serotonin","PET","Fenfluramine","[11C]Cimbi-36","SSRI","Serotonin Deficiency Theory of Depression","NOT_YET_RECRUITING","2026-06-12",{"date":39,"type":40},"2026-06-16","ACTUAL",{"date":42,"type":21},"2026-07-01",{"date":44,"type":21},"2028-12",{"name":46,"class":47},"Imperial College Healthcare NHS Trust","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":48},"100607678","mechanisms-affecting-the-gut-of-preterm-infants-receiving-blood-transfusion-with-different-enteral-feed-interventions-100607678","NCT07191678","Mechanisms Affecting the Gut of Preterm Infants Receiving Blood Transfusion With Different Enteral Feed Interventions","MAGPIE-2","Inclusion Criteria:\n\n* Very preterm babies (born between 23 to \\\u003C30 weeks of gestational age ) in the WHEAT International trial\n* Written informed consent from parents\n\nExclusion Criteria:\n\n* Babies who are deemed too unstable to perform the non-invasive monitoring and the ultrasound scan measurements by the attending clinical team\n* Babies who have already developed Bells stage 2 NEC, had bowel surgery or congenital abdominal conditions such as congenital diaphragmatic hernia, gastroschisis and exomphalos","23 Weeks","30 Weeks",{"count":59,"type":21},270,"OBSERVATIONAL","MAGPIE-2 is a prospective observational study designed to investigate the physiological mechanisms linking blood transfusion and enteral feeding practices to gut perfusion and oxygenation in very preterm infants. The study is nested within the WHEAT International randomised controlled trial, which compares two standard care approaches: withholding versus continuing milk feeds during red blood cell transfusion. While WHEAT evaluates clinical outcomes such as necrotising enterocolitis (NEC), MAGPIE-2 focuses on the underlying physiological changes that may contribute to NEC development.\n\nNEC is a serious gastrointestinal condition affecting approximately 10% of extremely preterm infants and is associated with high mortality and long-term neurodevelopmental impairment. Previous observational studies have suggested a temporal link between blood transfusion and NEC onset, particularly when feeds are continued during transfusion. However, the mechanisms remain poorly understood.\n\nMAGPIE-2 will use non-invasive monitoring tools-near-infrared spectroscopy (NIRS) and Doppler ultrasound-to measure cerebral and splanchnic (gut) tissue oxygenation and superior mesenteric artery (SMA) blood flow. These measurements will be used to calculate the Splanchnic-Cerebral Oxygenation Ratio (SCOR), a validated marker of gut tissue perfusion and ischaemia. A reduction in SCOR may indicate compromised gut oxygenation, potentially contributing to NEC.\n\nThe study will recruit 270 infants (135 per arm) already enrolled in the WHEAT trial. Weekly measurements will be taken until 34 weeks corrected gestational age or discharge. Peri-transfusion monitoring includes continuous NIRS from 4 hours before to 4 hours after transfusion, and additional 2-hour recordings at approximately 24 and 48 hours post-transfusion. SMA Doppler assessments will be performed weekly.\n\nPrimary outcomes include changes in SCOR post-transfusion between the two feeding strategies. Secondary outcomes include changes in cerebral and splanchnic oxygenation, SMA blood flow velocities, and the impact of severe anaemia (pre-transfusion haemoglobin ≤80 g\u002FL) on these parameters. The study also includes an assessment of inter-operator variability in Doppler measurements.\n\nMAGPIE-2 aims to provide mechanistic insights that could inform safer transfusion and feeding practices in neonatal care, potentially reducing the incidence of NEC in this vulnerable population.",[63,64,65,66],"NEC - Necrotizing Enterocolitis","NEC","Preterm Babies","Preterm Infant Health",[64,68,69,70],"Necrotizing Enterocolitis","Necrotising Enterocolitis","Preterm","RECRUITING","2026-03-26",{"date":74,"type":40},"2026-04-01",{"date":76,"type":40},"2025-11-03",{"date":78,"type":21},"2027-04-30",{"name":46,"class":47},{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":48},"100629431","oprestore-ai-patient-navigator-study-100629431","NCT07474584","OpRESTORE AI-Patient Navigator Study","The OpRESTORE AI-Patient Navigator Study: Developing and Testing an AI-enhanced Patient Navigator for UK Veterans With Service-related Physical Health Problems","Inclusion Criteria:\n\n* Meets criteria for referral to OpRESTORE service\n* Age 18 years or older.\n* Capacity to consent.\n* Have a physical health need (e.g. not purely mental health, or seeking social care advice)\n\nExclusion Criteria:\n\n* Referrals processed outside standard MDT workflow.\n* Patients lacking capacity to consent.\n* Prisoners.\n* Acute presentation best managed by emergency services and not appropriate for OpRESTORE.","18 Years",{"count":89,"type":21},1389,[24],"OpRESTORE is a national NHS service that supports UK veterans with complex physical health problems linked to their military service. Veterans referred to OpRESTORE often need care from many different specialists, including surgeons, pain teams, rehabilitation, and mental health services. Currently, decisions about which service is most appropriate are made by a multidisciplinary team (MDT) of clinicians. While effective, this process can be slow, resource-intensive, and sometimes difficult for patients to navigate.\n\nThis study will develop and test a new digital \"navigator\" tool that uses artificial intelligence (AI) to support these referral decisions. The aim is to see whether the tool can safely and accurately match veterans to the right care pathway, while reducing delays and improving patient experience.\n\nThe project will be carried out in several stages:\n\n* Reviewing past OpRESTORE records to design the AI model.\n* Testing the tool alongside the MDT (\"shadow testing\") to check whether its recommendations match the clinical decisions.\n* Running a case-control study to compare outcomes between patients referred using AI support and those referred by the MDT alone.\n* Creating and testing a structured self-referral form to make it easier for veterans to access care directly.\n\nThe main outcome will be whether the AI tool makes the same referral decisions as the MDT. Other outcomes include patient satisfaction, quality of life, time taken to reach the right service, and overall costs.\n\nThe study will recruit veterans aged 18 or older who are referred to OpRESTORE with a physical health need. It will run for two years. If successful, this approach could free up clinician time, shorten waits for treatment, and improve veterans' health and wellbeing, while laying the foundations for wider use of AI-supported navigation across the NHS.",[93],"Veteran",[95,96,97],"healthcare navigation","veteran healthcare","clinical AI","2026-03-11",{"date":100,"type":40},"2026-03-16",{"date":102,"type":21},"2026-05-01",{"date":104,"type":21},"2027-11-01",{"name":46,"class":47},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":114,"minAge":87,"maxAge":4,"enrollmentInfo":115,"targetDuration":117,"studyType":60,"phases":4,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":48},"100578890","ovarian-cancer-radiomics-approach-in-ct-led-evaluation-100578890","NCT06817174","Ovarian Cancer Radiomics Approach in CT Led Evaluation","Prospective Validation of CT Based Radiomic Models to Predict Surgical and Clinical Outcomes in Advanced Epithelial Ovarian Cancer","ORACLE","Inclusion Criteria:\n\n* Written (signed and dated) informed consent\n* Age 18 years or over\n* Suspected or confirmed advanced epithelial ovarian cancer (FIGO stage 3B or more)\n* Being considered for active anticancer treatment i.e. primary cytoreductive surgery followed by chemotherapy or neoadjuvant chemotherapy followed by interval cytoreductive surgery\n* Evaluable baseline portal venous phase CT scan prior to surgical or medical treatment for ovarian cancer\n* Disease visible on pre-treatment portal venous phase baseline CT scan (≥2cm)\n\nExclusion Criteria:\n\n* Known contra-indication to CT with IV contrast (e.g. contrast allergy, renal failure, inability to lie flat);\n* Unable to give informed consent;\n* Known pregnancy;\n* No visible disease \\\u003C2cm on portal venous phase baseline CT scan;\n* Previous surgery for resection of an adnexal mass;\n* Significant artefact on CT image for example from metal prostheses that precluded meaningful segmentation of visible disease\n* Only fit for palliative care at initial presentation","FEMALE",{"count":116,"type":21},168,"5 Years","When patients have suspected or confirmed ovarian cancer standard treatment will involve surgery and chemotherapy. However, as with any treatment, it is challenging to predict treatment response in advance. Before treatment, all patients have a CT scan to describe where the cancer is in order to guide the treatment.\n\nThere is now a new way to analyse routine scans using advanced computing methods, which may give more information about the ovarian cancer. This is called radiomics which analyses features in scans that are not visible to the naked eye. Our group at Imperial College London has worked on developing radiomic models to better understand ovarian cancer.\n\nThis study aims to determine whether the information gained from this new approach would help us to tailor patient treatment plans to better meet the patient's individual needs, even more than done already. Furthermore, the aim is to understand how different types of ovarian cancer can correlate with the radiomic findings, which may help develop potential treatments in the future.",[120],"Ovarian Cancer",[122,123,124,125,126,127],"Ovarian cancer","Radiomics","CT","Prognosis","Epithelial ovarian cancer","Biomarkers","2025-06-26",{"date":130,"type":40},"2025-06-27",{"date":132,"type":40},"2025-02-10",{"date":134,"type":21},"2032-01",{"name":46,"class":47},{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":48},"100556514","cerebral-oxygen-saturation-monitoring-during-optimum-cord-management-in-preterm-infants-100556514","NCT06526091","Cerebral Oxygen Saturation Monitoring During Optimum Cord Management in Preterm Infants","Cerebral Oxygen Saturation Monitoring During Optimum Cord Management in Preterm (COSMIC Pilot Study)","COSMIC","Inclusion Criteria:\n\n* All babies eligible for optimum cord management born before 34 completed weeks gestational age\n* Parental consent\n\nExclusion Criteria:\n\n* Multiple pregnancies\n* Infants for whom resuscitation at birth is not appropriate\n* Antenatal or immediate postnatal diagnosis of severe congenital anomaly\n* Infants with complex congenital cardiac disease","1 Minute","24 Hours",{"count":147,"type":21},40,"This study will assess the feasibilty measuring cerebral oxygen saturations using a Near Infrared Spectroscopy (NIRS) monitor immediately after delivery of preterm infants. The investigators aim to evaluate the effects of optimum cord management on cerebral oxygenation in this cohort",[150],"Pre-Term","2024-07-26",{"date":153,"type":40},"2024-07-29",{"date":155,"type":40},"2023-02-15",{"date":157,"type":21},"2024-10-01",{"name":46,"class":47},{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},"100417821","bioimpedence-and-arterial-function-monitoring-at-birth-and-in-infants-100417821","NCT04720690","Bioimpedence and Arterial Function Monitoring at Birth and in Infants","Bioimpedence and Arterial Function Monitoring at Birth and in Infants: the BAMBI Study","BAMBI","Inclusion Criteria:\n\n* Healthy term infants (including those with SGA+\u002F-FGR) in the postnatal ward\n* Term and Preterm infants (including those with SGA+\u002F-FGR) admitted to the neonatal unit\n* Written informed parental consent\n\nExclusion Criteria:\n\n* Antenatal or postnatal diagnosis of complex\u002Flife-limiting congenital anomaly or genetic condition\n* Infants with no realistic chance of survival\n* Infants with fragile skin not permitting use of cuffs for research purposes\n* Babies whose parents have a limited understanding of English will be excluded in the event that communication via NHS translation services is not possible due to clinical demands on these services","6 Months",{"count":169,"type":21},120,"Babies may be born appropriately grown for gestational age (AGA, \\>10th centile) or small for gestational age (SGA, \\\u003C10th centile). Babies who are SGA and have evidence in utero of vascular compromise using antenatal doppler indices are classified as having fetal growth restriction (FGR). Babies with FGR are at increased risk of cardiovascular disease in adult life. Increased arterial stiffness and intima-media thickness are thought to mediate this risk in adults. It is not known how early in life these changes can be robustly detected. In addition, very little is known generally about how babies' hearts and arteries change in structure and function over the first year of life, whether affected by SGA or not. This study aims to understand if there are differences in cardiac and arterial structure and function between babies born AGA or SGA. Within the group of SGA babies, the study team will investigate whether FGR and maternal pre-eclampsia influence these measurements. The effects gestational age on these parameters will be studied within all groups: half of the babies recruited will be \\\u003C32 weeks gestational age (GA), and half will be ≥32 weeks GA. Study participants will have further measurements at 3-6 months of life to assess if cardiac and arterial structure and function change in babies over the first year of life. The study team will use the Vicorder device to measure arterial stiffness, and assess the feasibility of using this device in neonates. The Vicorder will also be used to measure cardiac output. The feasibility and validity of this device for this purpose will be investigated (Vicorder is not validated for cardiac output measurement in infants). Vicorder cardiac output results will be compared to echocardiography and bioimpedence technology (using the NICaS monitor). The study team will use ultrasound for arterial structure measurements of the carotid artery and aorta.",[172,173,174,175],"Arterial Stiffness","Fetal Growth Retardation","Small for Gestational Age at Delivery","Pre-Eclampsia",{"date":153,"type":40},{"date":178,"type":40},"2020-12-01",{"date":180,"type":21},"2024-12-31",{"name":46,"class":47},2,{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":17,"minAge":190,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":194,"conditions":195,"keywords":199,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":204,"locationsCount":48},"100367430","non-invasive-continuous-cardiac-output-monitoring-in-preterm-infants-study-100367430","NCT04064177","Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study","NICCOM","Inclusion Criteria:\n\n* Healthy term infants in postnatal ward (within the first 72 hours of age)\n* Term and Preterm infants (including those with FGR) admitted to the neonatal unit\n* Written informed parental consent (prospective for postnatal ward and retrospective for babies admitted to the neonatal units)\n\nExclusion Criteria:\n\n* Antenatal or postnatal diagnosis of severe congenital anomaly\n* Infants with no realistic chance of survival\n* Infants who are \\>12 hours of age\n* Infants with fragile skin not permitting skin probe placement","1 Hour","40 Weeks",{"count":193,"type":21},148,"This is an observational study in newborn term and preterm infants. The study will validate if non-invasive continuous cardiac output monitoring is feasible in newborn infants, if normative values can be constructed and what is the effect of fluid boluses and inotropes on cardiac output and peripheral vascular resistance.",[196,197,198],"Cardiac Output, Low","Cardiac Output, High","Blood Pressure",[198],{"date":153,"type":40},{"date":202,"type":40},"2019-10-24",{"date":180,"type":21},{"name":46,"class":47},{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":114,"minAge":87,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":215,"briefSummary":216,"conditions":217,"keywords":221,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":48},"100554650","pipelle-under-ultrasound-guidance-pug-to-investigate-post-menopausal-bleeding-100554650","NCT06501846","Pipelle® Under Ultrasound Guidance (PUG) to Investigate Post-menopausal Bleeding.","Pipelle® Under Ultrasound Guidance (PUG) to Investigate Post-menopausal Bleeding: Randomised Controlled Trial.","PUG","Inclusion Criteria:\n\n* All patients with post-menopausal bleeding who require an endometrial biopsy.\n\nFurther details:\n\n* Post-menopausal bleeding is defined as bleeding one year after a woman's last menstrual period or bleeding six months after starting continuous combined hormone replacement therapy.\n* There is no upper age limit, however all patients must be 18 or above.\n\nStrict ultrasound criteria will be followed:\n\n* Endometrium ≥5mm: this is the current cut off used by Imperial College Healthcare NHS Trust for a biopsy to be indicated in the context of post-menopausal bleeding.\n* Smooth, homogenous endometrium with a clearly defined border.\n\nExclusion Criteria:\n\n* Focal endometrial pathology (including but not limited to endometrial polyps, type 0-2 fibroids, uterine septa and other uterine structural abnormalities).\n* Suspicion of non-benign myometrial pathology.\n* History of endometrial cancer or endometrial hyperplasia.\n* History of cervical cancer.\n* Virgo intacta.\n* Inability to tolerate vaginal examination.\n* Inability to consent.\n* The denial or withdrawal of informed written consent.",{"count":214,"type":21},92,[24],"TITLE Pipelle® under Ultrasound Guidance (PUG) to investigate post-menopausal bleeding: Randomised Controlled Trial\n\nBACKGROUND Women who are suspected of having endometrial cancer (cancer of the inner lining of the womb) due to vaginal bleeding after the menopause must have a tissue sample taken from this area to determine whether there is an abnormality.\n\nOne method of doing this is by using a small biopsy device (such as a Pipelle®) in the outpatient setting. This is referred to as an outpatient endometrial biopsy. However, a significant number of attempted endometrial biopsies are unsuccessful in obtaining a sample that is adequate for laboratory (histopathological) assessment. When an adequate sample is not obtained patients must then undergo more invasive testing.\n\nAIM This trial will use an ultrasound probe placed on the lower stomach (transabdominal ultrasound) to try and guide the doctor performing the endometrial biopsy with the aim of increasing the number of adequate samples that are obtained.\n\nThe trial will also investigate if this technique is less painful and more acceptable to patients, and if the time taken for patients to receive definitive treatment after their biopsy is reduced.\n\nELIGIBILITY All patients presenting with post-menopausal bleeding who have an endometrial thickness of 5mm or above without a contraindication to an outpatient endometrial biopsy.\n\nDESIGN Prospective randomised controlled trial enrolling 92 patients. When patients are entered into the study they will randomly assigned to one of two groups. One group will have their biopsy performed under transabdominal ultrasound guidance and the other will have the biopsy performed using the traditional 'blind' approach without ultrasound guidance. There will be 46 patients in each group.\n\nDURATION The trial will run for three years. The trial will be performed in the outpatient gynaecological oncology department at Queen Charlotte's and Chelsea Hospital, part of Imperial College Healthcare NHS Trust.",[218,219,220],"Endometrial Cancer","Post-Menopausal Bleeding","Endometrial Hyperplasia",[222,223],"Pipelle Endometrial Biopsy","Ultrasound Guidance","2024-07-11",{"date":226,"type":40},"2024-07-15",{"date":228,"type":21},"2024-07-23",{"date":230,"type":21},"2027-07-23",{"name":46,"class":47},""]