AI-Assisted Bronchoscopy Navigation and Diagnostic System for Severe Pneumonia: A Multicenter Pro… (NCT07230431) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
AI-Assisted Bronchoscopy Navigation and Diagnostic System for Severe Pneumonia: A Multicenter Prospective Study
100 participantsStarted 2025-11
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years.
. Severe pneumonia requiring clinically indicated bronchoscopy for diagnosis and/or therapy, as determined by the treating team.
. Written informed consent from the patient or a legally authorized representative.
. Expected to tolerate bronchoscopy with current respiratory support (e.g., HFNC/NIV/IMV) per site protocol
Exclusion criteria
. Standard contraindications to bronchoscopy, such as uncontrolled hypoxemia despite support (SpO2 \<90% for ≥30 s on FiO2 ≥0.60), hemodynamic instability requiring escalating vasopressors, or malignant arrhythmia not controlled.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic agreement versus central adjudication
Timeframe: From index bronchoscopy to central adjudication within 7 days
. Uncorrected coagulopathy likely to increase bleeding risk (e.g., platelets \<50×10\^9/L or INR \>1.5) per site policy.
. Known pregnancy or breastfeeding if the investigator judges risk outweighs benefit according to site policy.
. Participation in another interventional drug/device study that could interfere with outcomes.
. Any condition that, in the investigator's judgment, makes participation unsuitable (e.g., emergent life-saving bronchoscopy without time for consent).