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

Sponsor
Chinese Medical Association
Study ID
NCT07230431
Status
Not Yet Recruiting

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Conditions

  • Pneumonia
  • Respiratory Failure (Pediatric Patients)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • Conventional Bronchoscopy (Standard of Care) — OTHER
    Bronchoscopy per site routine without investigational AI assistance; no additional device or drug

Study Details

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.

Key Dates

First listed
Nov 17, 2025
Start date
Nov 30, 2025
Status verified
Oct 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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
  • Active Comparator: Conventional Bronchoscopy
    Standard-of-care bronchoscopy without investigational AI guidance. Indications, sedation, monitoring and post-procedure care follow site routine

Primary Outcome Measure

Diagnostic agreement versus central adjudication [ Time Frame: From index bronchoscopy to central adjudication within 7 days ]

Central Contacts

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