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Sd-RAB for the Diagnosis of PPLs

NCT06719687 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-06

No results posted yet for this study

Summary

This is a single-center, prospective, and single-arm study. The purpose of this study is to evaluate the feasibility and safety of a new self-driving robotic-assisted bronchoscopic system for the diagnosis of peripheral pulmonary lesions.

Conditions

  • Peripheral Pulmonary Lesions

Interventions

DEVICE

Self-driving robotic-assisted bronchoscope

All procedures will be performed under general anesthesia with endotracheal intubation and mechanical ventilation. The self-driving robotic-assisted bronchoscope will automatically advance through airway to the target lesion according to the preoperative planning path under the guidance of electromagnetic navigation. After that, the bronchoscopist will use radial endobronchial ultrasound (rEBUS) to confirm the lesion localization. The choice of biopsy tools (eg. forceps, needles, brush, etc.) will be left to the discretion of the bronchoscopist.

Sponsors & Collaborators

  • Shanghai Chest Hospital

    lead OTHER

Principal Investigators

  • Jiayuan Sun · Shanghai Chest Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2025-01-31
Completion
2025-02-28

Countries

  • China

Study Locations

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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 NCT06719687 on ClinicalTrials.gov