[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610657":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":26,"responsibleParty":38,"collaborators":40,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":26,"enrollmentInfo":56,"targetDuration":26,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":73,"whyStopped":26,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":26},{"fullName":5,"class":6},"Chinese Medical Association","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AI-Assisted Bronchoscopy","EXPERIMENTAL","Bronchoscopy performed with the investigational embodied-intelligence assistance (EIBRONCH). The system provides real-time visual overlay and voice prompts to support segmental navigation and standardized endobronchial description. Physicians make all clinical decisions; sedation, monitoring, and post-procedure care follow site routine",[13],"Device: Embodied-Intelligence-Assisted Bronchoscopy Navigation and Diagnostic System (EIBRONCH)",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Bronchoscopy","ACTIVE_COMPARATOR","Standard-of-care bronchoscopy without investigational AI guidance. Indications, sedation, monitoring and post-procedure care follow site routine",[19],"Other: Conventional Bronchoscopy (Standard of Care)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Embodied-Intelligence-Assisted Bronchoscopy Navigation and Diagnostic System (EIBRONCH)","Software\u002Fhardware system integrated with the bronchoscopic image chain. Uses pre-procedure planning and in-procedure computer vision to provide real-time visual cues and voice prompts for airway navigation and lesion characterization. Decision-support only; not implanted; used during the bronchoscopy procedure",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"OTHER","Conventional Bronchoscopy (Standard of Care)","Bronchoscopy per site routine without investigational AI assistance; no additional device or drug",[15],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Ming Chen, MD","CONTACT","025-83106666","chenliuer2015@163.com",{"type":39,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[41,43],{"name":42,"class":28},"Nanjing University",{"name":44,"class":45},"Micro-Tech (Nanjing) Co., Ltd.","INDUSTRY","100610657","ai-assisted-bronchoscopy-navigation-and-diagnostic-system-for-severe-pneumonia-a-multicenter-prospective-study-100610657",false,"NCT07230431","AI-Assisted Bronchoscopy Navigation and Diagnostic System for Severe Pneumonia: A Multicenter Prospective Study","Development and Clinical Validation of an Embodied-Intelligence-Assisted Bronchoscopy Navigation and Diagnostic System: A Multicenter Prospective Study","EIBRONCH","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Severe pneumonia requiring clinically indicated bronchoscopy for diagnosis and\u002For therapy, as determined by the treating team.\n3. Written informed consent from the patient or a legally authorized representative.\n4. Expected to tolerate bronchoscopy with current respiratory support (e.g., HFNC\u002FNIV\u002FIMV) per site protocol\n\nExclusion Criteria:\n\n1. Standard contraindications to bronchoscopy, such as uncontrolled hypoxemia despite support (SpO2 \\\u003C90% for ≥30 s on FiO2 ≥0.60), hemodynamic instability requiring escalating vasopressors, or malignant arrhythmia not controlled.\n2. Uncorrected coagulopathy likely to increase bleeding risk (e.g., platelets \\\u003C50×10\\^9\u002FL or INR \\>1.5) per site policy.\n3. Known pregnancy or breastfeeding if the investigator judges risk outweighs benefit according to site policy.\n4. Participation in another interventional drug\u002Fdevice study that could interfere with outcomes.\n5. Any condition that, in the investigator's judgment, makes participation unsuitable (e.g., emergent life-saving bronchoscopy without time for consent).","ALL","18 Years",{"count":57,"type":58},100,"ESTIMATED","INTERVENTIONAL",[61],"NA","This study will evaluate an embodied-intelligence-assisted bronchoscopy navigation and diagnostic system for patients with severe pneumonia who require clinically indicated bronchoscopy. The system provides real-time visual cues and voice prompts to help physicians localize target lung segments and describe endobronchial findings; physicians remain fully responsible for all clinical decisions. The trial is designed as a prospective, multicenter, controlled study conducted at about ten hospitals in China, with an anticipated sample size of approximately 100 patients. The primary objective is to determine whether AI assistance improves diagnostic agreement compared with the reference assessment, while secondary objectives include navigation success (e.g., loss-of-path rate), procedure time, and complication rates. The results will provide evidence on the safety and effectiveness of AI-assisted bronchoscopy and support product validation and registration.",[64,65],"Respiratory Failure (Pediatric Patients)","Pneumonia",[67,68,69,70,71,72],"Severe pneumonia","Bronchoscopy","Navigation system","Artificial intelligence","Computer-assisted","Diagnostic support","NOT_YET_RECRUITING","2025-11-13",{"date":76,"type":77},"2025-11-17","ACTUAL",{"date":79,"type":58},"2025-11",{"date":81,"type":58},"2026-11",{"name":5,"class":6}]