Sd-RAB for the Diagnosis of PPLs

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Peripheral Pulmonary Lesions

Treatments: Device: Self-driving robotic-assisted bronchoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT06719687

KS24054

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Patients with peripheral pulmonary lesions

Experimental group

Description:

30 patients with peripheral pulmonary lesions who meet the inclusion and exclusion criteria will be prospectively enrolled. Self-driving robotic-assisted bronchoscopy will be performed to diagnose the lesions.

Treatment:

Device: Self-driving robotic-assisted bronchoscope