Sd-RAB for the Diagnosis of PPLs

Not Applicable

Not yet recruiting

• Conditions: Peripheral Pulmonary Lesions

• Registration Number: NCT06719687
• Lead Sponsor: Shanghai Chest Hospital

Brief 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.

Detailed Description

Self-driving robotic-assisted bronchoscope (Shanghai MicroPort MedBot (Group) Corporation Limited, China) is a new robotic-assisted bronchoscopic system that can automatically advance through airway according to the preoperative planning path under the guidance of electromagnetic navigation. It can also be controlled manually by the operator. In this study, 30 patients will be prospectively enrolled to evaluate the feasibility and safety of this new self-driving robotic-assisted bronchoscopic system for the diagnosis of peripheral pulmonary lesions. The primary endpoint of this study is the complication rate. The secondary endpoints include navigation success rate, diagnostic yield, rate of rEBUS confirmation, total examination time, navigation time, and duration of finding lesions.

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-01
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients older than 18 years old.
2. Chest imaging shows the presence of peripheral pulmonary lesions (defined as those lesions that are surrounded by pulmonary parenchyma and located below the segmental bronchus), which are suspected to be malignant and require a non-surgical biopsy.
3. Patients have good medical adherence and signed informed consent.

Exclusion Criteria

1. Contraindications for bronchoscopy.
2. Presence of concomitant endobronchial lesion during the bronchoscopy procedure.
3. The investigators believe that patient has other conditions that are not suitable for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Complication rate	1 month	The complications refer to the total of device or procedure related adverse events during or within 1 month after the operation.

Secondary Outcome Measures

Name	Time	Method
Navigation success rate	1 month	Navigation success is defined as confirmation of the target lesion under rEBUS or a bronchoscope tip-to-virtual lesion distance \<2 cm that allows lesion sampling. Cases in which a malignant or specific benign diagnosis is obtained are also considered as navigation success.
Diagnostic yield	1 month	Diagnostic yield of self-driving robotic-assisted bronchoscopy for peripheral pulmonary lesions.
Rate of rEBUS confirmation	During the procedure	rEBUS confirmation is defined as visualization of target lesion using rEBUS during the procedure.
Total examination time	During the procedure	Total examination time is defined from the time that the bronchoscope is inserted beyond the glottis, until the bronchoscope has been removed from the glottis after examination.
Navigation time	During the procedure	Navigation time is defined as the time from the start of the self-driving robotic-assisted bronchoscope advancing under the guidance of electromagnetic navigation to the insertion of the ultrasound probe.
Duration of finding lesions	During the procedure	Duration of finding lesions is defined from the insertion of the ultrasound probe to the withdrawal of the ultrasound probe.

Trial Locations

Locations (1)

Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China