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

NCT07230431 | Not Yet Recruiting DMC

• 1 other identifier: 2025-09-01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Respiratory Failure (Pediatric Patients); Pneumonia

Keywords

Severe pneumonia; Bronchoscopy; Navigation system; Artificial intelligence; Computer-assisted; Diagnostic support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Navigation success rate

  During the bronchoscopy procedure

• Procedure time to target segment (minutes)

  During the bronchoscopy procedure

Study Arms (2)

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

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

Other: Conventional Bronchoscopy (Standard of Care)

Interventions

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

AI-Assisted Bronchoscopy

Conventional Bronchoscopy (Standard of Care) OTHER

Bronchoscopy per site routine without investigational AI assistance; no additional device or drug

Conventional Bronchoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Chinese Medical Association: lead
• Nanjing University: collaborator
• Micro-Tech (Nanjing) Co., Ltd.: collaborator

MeSH Terms

Conditions

Respiratory Insufficiency; Pneumonia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Lung Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Ming Chen, MD

CONTACT

025-83106666; chenliuer2015@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-10