AI-Assisted Bronchoscopy Navigation and Diagnostic System for Severe Pneumonia: A Multicenter Prospective Study (EIBRONCH)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pneumonia; Respiratory Failure (Pediatric Patients)
• Intervention / Treatment: Device: Embodied-Intelligence-Assisted Bronchoscopy Navigation and Diagnostic System (EIBRONCH); Other: Conventional Bronchoscopy (Standard of Care)

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming Chen, MD; Phone Number: 025-83106666; Email: chenliuer2015@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years.
2. Severe pneumonia requiring clinically indicated bronchoscopy for diagnosis and/or therapy, as determined by the treating team.
3. Written informed consent from the patient or a legally authorized representative.
4. Expected to tolerate bronchoscopy with current respiratory support (e.g., HFNC/NIV/IMV) per site protocol

Exclusion Criteria:

1. 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.
2. Uncorrected coagulopathy likely to increase bleeding risk (e.g., platelets <50×10^9/L or INR >1.5) per site policy.
3. Known pregnancy or breastfeeding if the investigator judges risk outweighs benefit according to site policy.
4. Participation in another interventional drug/device study that could interfere with outcomes.
5. Any condition that, in the investigator's judgment, makes participation unsuitable (e.g., emergent life-saving bronchoscopy without time for consent).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-Assisted Bronchoscopy; 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	Device: 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
Active Comparator: Conventional Bronchoscopy; Standard-of-care bronchoscopy without investigational AI guidance. Indications, sedation, monitoring and post-procedure care follow site routine	Other: Conventional Bronchoscopy (Standard of Care); Bronchoscopy per site routine without investigational AI assistance; no additional device or drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From index bronchoscopy to central adjudication within 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	During the bronchoscopy procedure

Collaborators and Investigators

• Sponsor: Chinese Medical Association
• Collaborators: Nanjing University; Micro-Tech (Nanjing) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Bronchoscopy; Artificial intelligence; Navigation system; Severe pneumonia; Diagnostic support; Computer-assisted
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Insufficiency; Pneumonia; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2025-09-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No