[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mediastinal--chest-masses\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mediastinal--chest-masses":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,69],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100644397","feasibility-and-preliminary-performance-of-an-ai-prototype-for-digital-rose-during-ebus-tbna-and-peripheral-tbna-a-prospective-pilot-study-ai-rose-feas-100644397",false,"NCT07662967","Feasibility and Preliminary Performance of an AI Prototype for Digital ROSE During EBUS-TBNA and Peripheral TBNA: a Prospective Pilot Study (AI-ROSE-FEAS)","Preliminary Feasibility and Diagnostic Performance of an Investigational Artificial Intelligence Prototype for Digital Rapid On-Site Evaluation (ROSE) of Cytological Slides During Diagnostic Bronchoscopy With Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) and Peripheral Transbronchial Needle Aspiration: a Prospective Monocentric Pilot Study (AI-ROSE-FEAS)","AI-ROSE-FEAS","Inclusion Criteria\n\n* Age ≥ 18 years.\n* Clinical indication for diagnostic bronchoscopy with EBUS-TBNA for mediastinal lymphadenopathy and\u002For TBNA on peripheral lung lesions, according to ACCP\u002FERS-ESTS guidelines and the Unit's diagnostic pathways.\n* The procedure will be performed in two-person mode with IP-ROSE performed as per the center's SOP.\n* Ability to provide written informed consent.\n* Willingness to undergo the required follow-up.\n\nExclusion Criteria\n\n* Absolute contraindications to bronchoscopy.\n* Known histological diagnosis of the target lesion (except re-staging).\n* Concomitant interventional procedures that alter the standard sequence.\n* Inability to provide written informed consent.\n* Any condition that, in the investigator's judgment, compromises patient safety or the reliability of the data.","ALL","18 Years",{"count":20,"type":21},65,"ESTIMATED","6 Months","OBSERVATIONAL","Rapid On-Site Evaluation (ROSE) of cytological slides obtained during EBUS-TBNA improves diagnostic yield by providing real-time adequacy assessment and preliminary diagnostic orientation after each needle pass. In centers without a dedicated cytopathologist, ROSE is performed by a second interventional pulmonologist acting as a dedicated ROSE operator (interventional pulmonologist-performed ROSE, IP-ROSE), a model associated with good but variable diagnostic performance compared to cytopathologist-performed ROSE.\n\nThis study evaluates the feasibility and preliminary diagnostic performance of an investigational artificial intelligence prototype for digital ROSE. The prototype, developed in-house by the Principal Investigator, analyzes microscopic images of Diff-Quik stained cytological slides acquired through a dedicated digital microscope, together with basic clinical data, via API calls to a multimodal AI model. It produces two outputs: sample adequacy (appropriate\u002Fnot appropriate) and malignancy suspicion (benign\u002Fmalignant), each with a confidence score. The AI output is recorded in the study database for research purposes only and is not shown to the operator in real time; it does not influence clinical decisions during the procedure.\n\nThe study is a prospective, monocentric, observational pilot study enrolling 65 adult patients undergoing EBUS-TBNA or peripheral TBNA with IP-ROSE at a single interventional pulmonology unit. The primary statistical unit is the individual ROSE slide, with an expected 130 to 160 evaluable slides. Co-primary endpoints are: (1) technical feasibility of the AI prototype, defined as the proportion of slides with valid AI output within 90 seconds; and (2) AI accuracy for sample adequacy assessment compared to the definitive cytopathological diagnosis, with an expected 95% confidence interval precision of ±5.5%. Secondary endpoints include AI accuracy for malignancy suspicion, agreement between the AI prototype and the IP-ROSE operator, and AI output latency.\n\nThe AI prototype is not a commercially approved or CE-marked medical device. It was developed internally by the Principal Investigator for research purposes and is evaluated exclusively within this study. Data from this pilot study will inform the design of a subsequent confirmatory non-inferiority trial, which will be the subject of separate registration and ethical approval.",[26,27,28,29,30,31,32],"Lung Neoplasms","Bronchoscopy","AI (Artificial Intelligence)","Mediastinal ( Chest) Masses","Mediastinal Lymphadenopathy","EBUS Guided Transbronchial Needle Aspiration","Lung Cancer (Diagnosis)",[34,35],"bronchoscopy","artificial intelligence","NOT_YET_RECRUITING","2026-06-17",{"date":39,"type":40},"2026-06-23","ACTUAL",{"date":42,"type":21},"2026-07-01",{"date":44,"type":21},"2027-03",{"name":46,"class":47},"Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100625173","role-of-endoscopic-ultrasound-elastography-in-diagnosis-of-gastrointestinal-subepithelial-and-mediastinal-lesions-100625173","NCT07419191","Role of Endoscopic Ultrasound Elastography in Diagnosis of Gastrointestinal Subepithelial and Mediastinal Lesions","Inclusion Criteria:\n\n* Age: Adults ≥ 12 years.\n\n  * Clinical indication: Patients referred for diagnostic EUS of a 1\\_mediastinal mass or mediastinal lymphadenopathy detected on prior imaging (CT\u002FMRI) .\n\n    2- subepithelial lesions lesion detected by endoscopy .\n  * Lesion accessibility: Lesion judged by the endosonographer to be accessible to EUS imaging and elastography and amenable to EUS-guided sampling\n\nExclusion Criteria:\n\n* • patient Refusal or inability to provide informed consent\n\n  * Uncorrectable coagulation disorder\n  * Presence of contraindicating endoscopy\u002Fsedation\n  * Lesion inaccessible to EUS or elastography (e.g., too far from the esophagus\u002Fairway to obtain reliable elastography or visualization) as judged by the performing endosonographer.",{"count":55,"type":21},35,"The aim of this study is to evaluate the role of endoscopic ultrasound (EUS) in the diagnosis of mediastinal and gastrointestinal subepithelial lesions.\n\nThe study also aims to assess the diagnostic accuracy of endoscopic ultrasound (EUS) elastography in differentiating benign from malignant mediastinal and gastrointestinal subepithelial lesions.",[29,58],"Gastrointestinal Subepithelial Tumors","2026-02-16",{"date":61,"type":40},"2026-02-18",{"date":63,"type":21},"2026-02-08",{"date":65,"type":21},"2027-12-30",{"name":67,"class":47},"Assiut University",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":4},"100608295","subxiphoid-vats-for-giant-mediastinal-teratoma-100608295","NCT07199699","Subxiphoid VATS for Giant Mediastinal Teratoma","The Safety and Efficacy of Subxiphoid Minimally Invasive Resection of Giant Mediastinal Teratoma Assisted by Double Sternal Elevation","Inclusion Criteria:\n\n* Age: 10 - 70 years old, gender unrestricted; Preoperative enhanced CT or MRI confirms anterior mediastinal mass with the maximum diameter ≥ 7 cm; Intraoperative frozen section pathology confirms teratoma (mature or immature type); American Society of Anesthesiologists (ASA) classification grade I - III, with acceptable cardiopulmonary function for single-lung ventilation; No severe thoracic deformity or severe adhesion in the posterior mediastinum (assessed by preoperative imaging); Patients voluntarily sign the informed consent form, understanding the purpose and potential risks of the study.\n\nExclusion Criteria:\n\n* Tumors invading major blood vessels (such as the innominate vein, superior vena cava, or aorta) or the pericardium require combined vascular\u002Fpericardial resection and reconstruction; Tumors crossing the midline and encasing the trachea or esophagus require multidisciplinary joint surgery; Previous mediastinal surgery or radiotherapy history, leading to local anatomical structure disorder; Coagulation dysfunction (INR \\> 1.5 or platelet count \\\u003C 50×10⁹\u002FL); Severe immune deficiency (such as HIV infection, long-term glucocorticoid treatment); Pregnant or lactating women; Concurrent other malignant tumors (metastatic lesions need to be excluded); Severe cardiopulmonary diseases (such as COPD GOLD Ⅲ-Ⅳ grade, NYHA cardiac function Ⅲ-Ⅳ grade); Mental illness or cognitive impairment that cannot cooperate with postoperative follow-up; Participated in other clinical trials that may interfere with the results of this study.","10 Years","70 Years",{"count":79,"type":21},40,"INTERVENTIONAL",[82],"NA","For giant mediastinal teratomas, the only treatment option available is usually open-chest surgery, which causes significant trauma, leads to obvious postoperative pain and may result in long-term complications such as chest wall deformity. Currently, we have developed a new treatment method. We use a double retractor system to pull the upper and lower ends of the sternum, lifting it to obtain sufficient surgical space behind the sternum. This enables us to perform minimally invasive tumor resection through the subxiphoid approach with thoracoscopy. The advantages of this method include reduced surgical trauma and postoperative pain, shortened hospital stay, and improved cosmetic effect",[85,29,86],"Teratomas","VATS","2025-09-26",{"date":89,"type":40},"2025-09-30",{"date":91,"type":21},"2025-11-01",{"date":93,"type":21},"2027-06-30",{"name":95,"class":47},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine"]