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NCT Number: NCT06719687

Sd-RAB for the Diagnosis of PPNs

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 nodules.

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Key information

Conditions

Peripheral Pulmonary Nodules

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

About this study

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 nodules.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients older than 18 years old.
  • Presence of a peripheral pulmonary nodule (8 mm < diameter ≤ 30 mm) on thin-section chest CT that is suspected to be malignant and requires non-surgical biopsy.
  • Patients have good medical adherence and signed informed consent.

Exclusion criteria

  • Presence of contraindications to bronchoscopy under general anesthesia.
  • Presence of concomitant endobronchial lesion during the bronchoscopy procedure.
  • The investigators believe that patient has other conditions that are not suitable for the study.

Treatment and study plan

Self-driving robotic-assisted bronchoscope

Device

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.

Primary outcomes

  1. Navigation success rate

    Time frame: 1 month

    Navigation success is defined as: (1) confirmation of the target lesion under rEBUS and/or fluoroscopy that allows lesion sampling, (2) positioning of the bronchoscope tip within ≤3 cm of the virtual lesion that allows lesion sampling, or (3) acquisition of a malignant or specific benign diagnosis via the procedure.

Secondary outcomes

  1. Diagnostic yield

    Time frame: 1 month

    A procedure is deemed diagnostic if a specific benign or malignant diagnosis is made.

  2. Rate of rEBUS confirmation

    Time frame: During the procedure

    rEBUS confirmation is defined as visualization of target lesion using rEBUS during the procedure.

  3. Total examination time

    Time frame: 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.

  4. Navigation time

    Time frame: 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.

  5. Duration of finding lesions

    Time frame: During the procedure

    Duration of finding lesions is defined from the insertion of the ultrasound probe to the withdrawal of the ultrasound probe.

  6. Complication rate

    Time frame: 1 month

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jiayuan Sun, MD, PhD

CONTACT

[email protected]

86-021-22200000 ext. 1511

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study title

Self-driving Robotic-assisted Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 6, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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