[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ovarian-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ovarian-diseases":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,81,107],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100579755","a-clinical-study-on-the-feasibility-and-safety-of-abdominal-endoscopic-single-port-surgery-system-to-assist-gynecological-day-surgery-100579755",false,"NCT06828419","A Clinical Study on the Feasibility and Safety of Abdominal Endoscopic Single-port Surgery System to Assist Gynecological Day Surgery","Inclusion Criteria:\n\n1. Women aged 18 to 75 years old, with a body mass index (BMI) of no more than 32 kg\u002Fm2;\n2. Conscious, no history of mental illness, accompanied by an adult during the perioperative period;\n3. Educate the subjects, who are willing to undergo day surgery, understand and accept the surgical method and anesthesia method;\n4. Subjects and families understand perioperative care and are willing and able to complete post-discharge care;\n5. Elective surgery, no serious complications affecting the operation and prognosis, aCCI age adjusted comorbidity index 0 points;\n6. According to the adhesion risk scoring system of European Anti-Adhesions in Gynaecology Expert Panel (ANGEL), the adhesion risk was divided into three levels: high, medium and low. Subjects with low risk (0 to 12 points) and abdominal wall scarring and pelvic cavity B-ultrasonography do not indicate obvious pelvic cavity adhesion wiil be included.\n\nExclusion Criteria:\n\n1. Moderate and high-risk patients will be excluded based on ANGEL adhesion risk scoring system;\n2. Subjects with hemorrhagic rupture of ectopic pregnancy and unstable vital signs;\n3. Genital tract infection or in the acute phase of systemic infection;\n4. Subjects on long-term anticoagulant therapy or with coagulation dysfunction;\n5. Subjects have severe heart and lung disease, liver and kidney dysfunction, and cannot tolerate anesthesia;\n6. A history of abdominal or diaphragmatic hernia, abnormal umbilical cord development, or umbilical surgery;\n7. Not willing to undergo endoscopic surgery;\n8. Participated in other drug and device clinical trials within 3 months before surgery.","FEMALE","18 Years","75 Years",{"count":19,"type":20},63,"ESTIMATED","INTERVENTIONAL",[23],"NA","In this study, a prospective study is used to select patients who will undergo intra-abdominal endoscopic single-port surgery system for benign gynecological diseases from February 2025 to December 2026 in the Second Affiliated Hospital of Wenzhou Medical University, including hysterectomy, myomectomy, ovarian cyst removal and adnexectomy. The study will perform statistical analysis to evaluate the feasibility and the main factors affecting the safety of intra-abdominal endoscopic single-port surgery system(SR-ENS-600) used in gynecological day surgery.",[26,27,28,29,30,31,32],"Adenopathy","Uterine Fibroids","Ovarian Cysts","Adnexal Mass","Ovarian Diseases","Adnexal Cyst","Adnexal Diseases",[34,35,36],"robotic-assisted laparoscopic single-site surgery (R-LESS)","single-port robot system (SPRS)","day surgery","NOT_YET_RECRUITING","2025-03-27",{"date":40,"type":41},"2025-04-03","ACTUAL",{"date":43,"type":20},"2025-04-10",{"date":45,"type":20},"2026-12-31",{"name":47,"class":48},"Second Affiliated Hospital of Wenzhou Medical University","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":79,"locationsCount":4},"100573724","4k-versus-3d-total-laparoscopic-bilateral-oophorectomy-tools-in-comparison-100573724","NCT06750003","4K Versus 3D Total Laparoscopic Bilateral Oophorectomy: Tools in Comparison","4K Versus 3D Total Laparoscopic Bilateral Oophorectomy by Surgeons in Training: Tools in Comparison","TOLSTOY","Inclusion Criteria:\n\n* Patients with benign ovarian pathology requiring bilateral oophorectomy\n* ASA score \\\u003C3\n* Patients who have signed the appropriate informed consent\n* Patients who are not pregnant or diagnosed with pelvic inflammatory disease\n* No history of prior major abdominal surgery\n\nExclusion Criteria:\n\n* Suspected neoplastic pathology\n* Patients not eligible for surgery",{"count":59,"type":20},22,[23],"Evaluate whether the 4K laparoscopic vision system can provide an advantage in performing bilateral oophorectomy procedures for benign conditions carried out by trainee surgeons compared to 3D laparoscopy",[30],[64,65,66,67,68,69,70,71,72],"Benign ovarian disease","laparoscopy","annessiectomy","ovariectomy","resident","tridimensional","high definition surgery","3D","4K","2024-12-19",{"date":75,"type":41},"2024-12-27",{"date":77,"type":20},"2024-12-15",{"date":45,"type":20},{"name":80,"class":48},"Azienda Sanitaria-Universitaria Integrata di Udine",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":49},"100497175","phase-2-adebrelimab-combined-with-fuzuloparib-in-the-treatment-of-patients-with-recurrent-platinum-resistant-ovarian-cancer-100497175","NCT05753826","Adebrelimab Combined With Fuzuloparib in the Treatment of Patients With Recurrent Platinum-resistant Ovarian Cancer.","A Single-arm, Exploratory Study of Adebrelimab Combined With Fuzuloparib in the Treatment of Patients With Recurrent Platinum-resistant Ovarian Cancer","Inclusion Criteria:\n\n1. Age 18-70;Female;\n2. Pathologically (including histologically) confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (hereinafter referred to as ovarian cancer), recurrence within less than 6 months after the last treatment with platinum-containing chemotherapy;\n3. Patients have at least one target lesion with measurable dimensions according to RECIST1.1 criteria;\n4. HRR gene mutation confirmed by testing tissue or blood samples;\n5. ECOG PS 0-1;\n6. Major organ functions are normal and meet the following criteria:(1) Blood routine inspection standards must meet: (no blood transfusion within 14 days)a.HB≥100g\u002FL, b. WBC≥3×10\\^9\u002FL c. ANC≥1.5×10\\^9\u002FL, d.PLT≥100×10\\^9\u002FL; (2) Biochemical examination must meet the following standards: a. BIL ≤1.5 times the upper limit of normal (ULN); b. ALT and AST≤2.5×ULN, ALT and AST≤5×ULN in patients with liver metastases; c. Serum Cr≤1.5×ULN\n7. Activated partial thromboplastin time (APTT) ≤ 1.5 times ULN, prothrombin time (PT) ≤ 1.5 times ULN, international normalized ratio (INR) ≤ 1.5 times ULN, unless the patient is receiving anticoagulation, as long as PT or APTT is within the expected range of anticoagulant use;\n8. No severe heart, lung, liver or kidney disorders;\n9. Women of childbearing age must have a pregnancy test (serum) within 7 days prior to enrollment and have a negative result, and be willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the test drug;\n10. Estimated survival≥ 12 weeks;\n11. Sign a written informed consent form and be able to comply with the visitation and related procedures set out in the programme.\n\nExclusion Criteria:\n\n1. Other clinical drug experiments in which other experimental research drugs are used concurrently with the study;\n2. Patients with known hypersensitivity to fluzoparib or hypersensitivity to drug-active or inactive ingredients with a similar chemical structure to fluzoparib;\n3. Patients with known hypersensitivity to adebrelimab or hypersensitivity to the active or inactive components of the drug having a similar chemical structure to adebrelimab;\n4. Inability to swallow oral medications and any gastrointestinal disorders that may interfere with the absorption and metabolism of study medications, such as uncontrolled nausea and vomiting, gastrointestinal obstruction or malabsorption;\n5. prior treatment with known or probable immune checkpoint inhibitors;\n6. Have any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Except vitiligo or recovered childhood asthma\u002Fallergies who do not require any intervention in adulthood; Autoimmune-mediated hypothyroidism treated with stable doses of thyroid-replacement hormones; Type I diabetes mellitus with a stable dose of insulin;\n7. A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation;\n8. With unstable systemic diseases, such as hypertension that cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥90 mmHg), severe arrhythmias, etc.;\n9. Previous or current idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, organising pneumonia, drug-induced pneumonia, or active pneumonia on screening-phase CT;\n10. There are cardiac clinical symptoms or diseases that are not well controlled, such as: (1) cardiac insufficiency above NYHA grade 2 (2) unstable angina (3) acute myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) QTc\\>470ms;\n11. Patients who are pregnant or breastfeeding, or who plan to become pregnant during study treatment;\n12. The investigators considered it unsuitable for inclusion.","70 Years",{"count":90,"type":20},37,[92],"PHASE2","This is a single-arm, exploratory study. People with recurrent platinum-resistant ovarian cancer who have not received any previous systemic antitumor therapy for ovarian cancer were selected to evaluate the efficacy and safety of adebrelimab combined with fuzuloparib.",[95,30],"Ovarian Neoplasms","RECRUITING","2024-02-04",{"date":99,"type":41},"2024-02-06",{"date":101,"type":41},"2023-08-01",{"date":103,"type":20},"2027-12-31",{"name":105,"class":106},"Fujian Cancer Hospital","OTHER_GOV",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":125,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":49},"100402352","phase-2-pembrolizumab-and-lenvatinib-for-platinum--sensitive-recurrent-ovarian-cancer-100402352","NCT04519151","Pembrolizumab and Lenvatinib for Platinum- Sensitive Recurrent Ovarian Cancer","A Phase II, Open Lable, Single Arm, Trial to Determine Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab for Platinum- Sensitive Recurrent Ovarian Cancer","Inclusion Criteria:\n\n1. Female participants who are at least 18 years of age on the day of signing informed consent, with histologically-confirmed diagnosis of EOC (except from low grade tumors and mucinous histology).\n2. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n   1. Not a woman of childbearing potential (WOCBP) OR\n   2. A WOCBP who agrees to follow the contraceptive during the treatment period and for at least 120 days after the last dose of study treatment.\n3. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n4. Have measurable disease at baseline based on RECIST 1.1. Lesions\n5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n6. Have received a front-line platinum-based regimen per local standard of care or treatment guideline following the primary or interval debunking surgery with radiologically documented disease recurrence no earlier than 6 months following completion of platinum-based therapy.\n\nNote: Maintenance treatment following front-line treatment is permitted and counted together as part of the front-line treatment. Recurrence is evaluated since last platinum-based chemotherapy administration (for patients treated with maintenance bevacizumab or PARP inhibitors) Note: Patients that received maintenance immune checkpoint inhibitors will be eligible if progression was documented over 6 months since completion of the immunotherapy maintenance treatment.\n\nHave received 0 to 1 line of chemotherapy for ROC (or 1 to 2 total prior lines counting the front line) and must have a PFI (or treatment-free interval) of \\>6 months for each treatment line.\n\n8\\. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.\n\n9\\. Have adequately controlled blood pressure (BP) with or without antihypertensive medications 10. Have adequate organ function as defined by blood tests.\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive urine pregnancy test\n2. The participant is pregnant or breastfeeding at Screening or Baseline, or is expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n3. The participant has received prior therapy with an anti-PD-1, anti-PD-L1 oranti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137) in the last 6 months (6 months are calculated from the last dose until study initiation).\n4. The participant has received prior systemic anti-cancer therapy mAb, chemotherapy or targeted small molecule therapy within 4 weeks prior to the planned first dose of the study, including investigational agents within 4 weeks. For tyrosine kinase inhibitors (TKIs), other than lenvatinib, and hormonal therapy a shorter interval of 5 half-lives is allowed between prior therapy and study treatment initiation.\n\n   Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.\n5. The participant has received prior lenvatinib.\n6. The participant has received prior radiotherapy within 2 weeks of start of study treatment.\n7. The patient had prior grade 3 immune related toxicity due to immune checkpoint inhibitors or non-infectious pneumonitis.\n8. The participant has received more than 2 prior chemotherapy lines.\n9. The participant has a history of tumor bleeding one month before study enrollment.\n10. The participant has received a live vaccine within 30 days prior to the first dose of study drug.\n11. The participant is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.\n\n    Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.\n12. The participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n\n    Note: The use of physiologic doses of corticosteroids is allowed.\n13. The participant has a known active second\u002Fadditional malignancy that is progressing or has required active treatment within the past 5 years Note: Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer.\n14. The participant has a known active CNS metastases and\u002For carcinomatous meningitis.\n\n    Note: Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.\n15. The participant has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of excipients.\n16. The participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n\n    Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n17. The participant has an active infection requiring systemic therapy.\n18. The participant has a known history of human immunodeficiency virus (HIV 1\u002F2 antibodies).\n19. The participant has a known history of hepatitis B or known active hepatitis C virus\n20. The participant has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n21. The participant has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n22. The participant has had an active allogenic tissue\u002Fsolid organ transplant.\n23. The participant has uncontrolled blood pressure\n24. The participant has clinically significant electrolyte abnormalities that have not been corrected.\n25. The participant has significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA) within 6 months of the first dose of study drug, or cardiac arrhythmia associated with hemodynamic instability requiring medical treatment at Screening.\n26. The participant has bleeding or thrombotic disorders, radiographic evidence of major blood vessel invasion\u002Finfiltration, or is at risk for severe hemorrhage.\n\n    Note: The degree of tumor invasion\u002Finfiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage\u002Fnecrosis following lenvatinib therapy.\n27. The participant has \\>1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is \\\u003C1 g\u002F24 hours.\n28. Prolongation of QTc interval to \\>480 ms.\n29. Left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).\n30. The participant has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.\n31. The participant has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula.\n32. The participant has a known intolerance to the study treatment (or any of its excipients).",{"count":115,"type":20},24,[92],"This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) for the treatment of platinum sensitive recurrent ovarian cancer. Participants will receive pembrolizumab and lenvatinib.",[95,119,120,30,121,122,123,124],"Carcinoma, Ovarian Epithelial","Neoplasm of Stomach","Genital Neoplasms, Female","Ovarian Epithelial Tumor","Urogenital Neoplasms","Neoplasms, Glandular and Epithelial",[126,127,128,129,130],"Ovarian Cancer","Platinum sensitive","Ovarian Epithelial","Neoplasms","Genital Neoplasms","2023-06-06",{"date":133,"type":41},"2023-06-08",{"date":135,"type":41},"2021-04-12",{"date":137,"type":20},"2029-11",{"name":139,"class":106},"Sheba Medical Center"]