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

NCT07230431 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-11-17

No results posted yet for this study

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

Interventions

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

OTHER

Conventional Bronchoscopy (Standard of Care)

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

Sponsors & Collaborators

  • Nanjing University

    collaborator OTHER

  • Micro-Tech (Nanjing) Co., Ltd.

    collaborator INDUSTRY

  • Chinese Medical Association

    lead NETWORK

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2026-11-30
Completion
2026-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07230431 on ClinicalTrials.gov