Respiratory Failure (Pediatric Patients)EIBRONCHNCT07230431
AI-Assisted Bronchoscopy Navigation and Diagnostic System for Severe Pneumonia: A Multicenter Prospective Study
A study testing Embodied-Intelligence-Assisted Bronchoscopy Navigation and Diagnostic System (EIBRONCH) in people with Respiratory Failure (Pediatric Patients) and Pneumonia, run by Chinese Medical Association.
Trial summary
This study will evaluate an embodied-intelligence-assisted bronchoscopy navigation and diagnostic system for patients with severe pneumonia who require clinically indicated bronchoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure (Pediatric Patients), Pneumonia
- What is being tested?
- Embodied-Intelligence-Assisted Bronchoscopy Navigation and Diagnostic System (EIBRONCH)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development and Clinical Validation of an Embodied-Intelligence-Assisted Bronchoscopy Navigation and Diagnostic System: A Multicenter Prospective Study
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.
Read the detailed description
Rationale: Severe pneumonia often requires bronchoscopy for diagnosis and therapy, yet accurate segmental localization and consistent interpretation are operator-dependent and time-consuming. Prior work by the sponsor team integrated CT-based planning with real-time bronchoscopic guidance and AI-based lesion characterization. The investigational system overlays guidance and voice prompts during bronchoscopy to standardize navigation and reduce errors.
Design: Prospective multicenter controlled study in ICUs/respiratory units. Approximately 100 adults undergoing clinically indicated bronchoscopy for severe pneumonia will be enrolled across ~10 centers in China. Procedures will be performed either with AI assistance or with standard bronchoscopy per site workflow. Outcomes include: (1) diagnostic agreement versus a predefined reference (primary); (2) navigation success/loss-of-path; (3) procedure time; and (4) adverse events (e.g., bleeding, hypoxemia, infection). Enrollment is planned to start in Sep 2025, with anticipated primary completion around Sep 2026.
Operations: Data will be collected using a standardized CRF and analyzed per a prespecified SAP. The investigational software is integrated with an endoscopic image processor developed with an industry partner; physicians can follow or ignore AI suggestions at their discretion. The study will generate evidence on effectiveness and safety to inform subsequent registration testing and scaling.
- Being tested
- Embodied-Intelligence-Assisted Bronchoscopy Navigation and Diagnostic System (EIBRONCH), Conventional Bronchoscopy (Standard of Care)
- Keywords
- Severe pneumonia, Bronchoscopy, Navigation system, Artificial intelligence, Computer-assisted, Diagnostic support
- Medical subject headings
- Respiratory Insufficiency, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embodied-Intelligence-Assisted Bronchoscopy Navigation and Diagnostic System (EIBRONCH)Device
Software/hardware 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
Conventional Bronchoscopy (Standard of Care)Other
Bronchoscopy per site routine without investigational AI assistance; no additional device or drug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Embodied-Intelligence-Assisted Bronchoscopy Navigation and Diagnostic System (EIBRONCH) |
| Conventional Bronchoscopy | Active comparator | Standard-of-care bronchoscopy without investigational AI guidance. Indications, sedation, monitoring and post-procedure care follow site routine Receives: Other: Conventional Bronchoscopy (Standard of Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic agreement versus central adjudication
Participant-level proportion whose bronchoscopic diagnosis (target segment localization and lesion category) matches the reference standard defined by a blinded expert panel (≥2 senior bronchoscopists; disagreements resolved by a third reviewer) reviewing procedure images/videos and clinical data. Metric: percent agreement and Cohen's kappa with 95% CI; analysis unit: participant
Measured: From index bronchoscopy to central adjudication within 7 days
Secondary outcomes (2)
Navigation success rate
Participant-level proportion of procedures that successfully reach the prespecified target bronchial segment without any loss-of-path event (>10 s) requiring external repositioning or restarts. Analysis unit: procedure.
Measured: During the bronchoscopy procedure
Procedure time to target segment (minutes)
Minutes from scope insertion to confirmation of the prespecified target segment (via endobronchial landmarks and site protocol). Reported as mean (SD) or median (IQR) and between-arm difference with 95% CI.
Measured: During the bronchoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Failure (Pediatric Patients)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective multicenter parallel two-arm study comparing AI-assisted bronchoscopy with conventional bronchoscopy. Consecutive eligible adults undergoing clinically indicated bronchoscopy for severe pneumonia will be enrolled at \~10 hospitals in China. Participants are assigned to one of two arms per site protocol (non-randomized). In the AI arm, the investigational system provides real-time visual and voice guidance; standard of care is otherwise identical in both arms.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Collaborators
- Nanjing University, MICRO-TECH (Nanjing) Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230431
- Sponsor's protocol ID
- 2025-09-01
- Acronym
- EIBRONCH
- Status last verified
- Oct 2025
- First submitted
- 13 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Validation of an Embodied-Intelligence-Assisted Bronchoscopy Navigation and Diagnostic System: A Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT07230431
- Acronym / sponsor ID
- EIBRONCH / 2025-09-01
- Keywords
- Severe pneumonia, Bronchoscopy, Navigation system, Artificial intelligence, Computer-assisted, Diagnostic support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Collaborators
- Nanjing University, MICRO-TECH (Nanjing) Co., Ltd
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: Severe pneumonia often requires bronchoscopy for diagnosis and therapy, yet accurate segmental localization and consistent interpretation are operator-dependent and time-consuming. Prior work by the sponsor team integrated CT-based planning with real-time bronchoscopic guidance and AI-based lesion characterization. The investigational system overlays guidance and voice prompts during bronchoscopy to standardize navigation and reduce errors.
Design: Prospective multicenter controlled study in ICUs/respiratory units. Approximately 100 adults undergoing clinically indicated bronchoscopy for severe pneumonia will be enrolled across ~10 centers in China. Procedures will be performed either with AI assistance or with standard bronchoscopy per site workflow. Outcomes include: (1) diagnostic agreement versus a predefined reference (primary); (2) navigation success/loss-of-path; (3) procedure time; and (4) adverse events (e.g., bleeding, hypoxemia, infection). Enrollment is planned to start in Sep 2025, with anticipated primary completion around Sep 2026.
Operations: Data will be collected using a standardized CRF and analyzed per a prespecified SAP. The investigational software is integrated with an endoscopic image processor developed with an industry partner; physicians can follow or ignore AI suggestions at their discretion. The study will generate evidence on effectiveness and safety to inform subsequent registration testing and scaling.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective multicenter parallel two-arm study comparing AI-assisted bronchoscopy with conventional bronchoscopy. Consecutive eligible adults undergoing clinically indicated bronchoscopy for severe pneumonia will be enrolled at ~10 hospitals in China. Participants are assigned to one of two arms per site protocol (non-randomized). In the AI arm, the investigational system provides real-time visual and voice guidance; standard of care is otherwise identical in both arms.
| Arm | Type | Receives |
|---|---|---|
| AI-Assisted Bronchoscopy | Experimental | Device: Embodied-Intelligence-Assisted Bronchoscopy Navigation and Diagnostic System (EIBRONCH)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 |
| Conventional Bronchoscopy | Active comparator | Other: Conventional Bronchoscopy (Standard of Care)Standard-of-care bronchoscopy without investigational AI guidance. Indications, sedation, monitoring and post-procedure care follow site routine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embodied-Intelligence-Assisted Bronchoscopy Navigation and Diagnostic System (EIBRONCH)Software/hardware 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 | Device | AI-Assisted Bronchoscopy |
| Conventional Bronchoscopy (Standard of Care)Bronchoscopy per site routine without investigational AI assistance; no additional device or drug | Other | Conventional Bronchoscopy |
Primary outcome
Diagnostic agreement versus central adjudication
Time frame: From index bronchoscopy to central adjudication within 7 days
Participant-level proportion whose bronchoscopic diagnosis (target segment localization and lesion category) matches the reference standard defined by a blinded expert panel (≥2 senior bronchoscopists; disagreements resolved by a third reviewer) reviewing procedure images/videos and clinical data. Metric: percent agreement and Cohen's kappa with 95% CI; analysis unit: participant
2 secondary outcomes
Navigation success rate
Time frame: During the bronchoscopy procedure
Procedure time to target segment (minutes)
Time frame: During the bronchoscopy procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Embodied-Intelligence-Assisted Bronchoscopy Navigation and Diagnostic System (EIBRONCH) in people with Respiratory Failure (Pediatric Patients) and Pneumonia, run by Chinese Medical Association.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Chen, MD (025-83106666, chenliuer2015@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic agreement versus central adjudication (time frame: From index bronchoscopy to central adjudication within 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.