Sd-RAB for the Diagnosis of PPNs

NCT06719687 | Not Yet Recruiting

• 1 other identifier: KS24054
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 nodules.

Conditions

Peripheral Pulmonary Nodules

Outcome Measures

Primary Outcomes (1)

• Navigation success rate

  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.

  1 month

Secondary Outcomes (6)

• Diagnostic yield

  1 month

• Rate of rEBUS confirmation

  During the procedure

• Total examination time

  During the procedure

• Navigation time

  During the procedure

• Duration of finding lesions

  During the procedure

Study Arms (1)

Patients with peripheral pulmonary nodules

EXPERIMENTAL

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

Device: Self-driving robotic-assisted bronchoscope

Interventions

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.

Patients with peripheral pulmonary nodules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Study Officials

• Jiayuan Sun

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiayuan Sun, MD, PhD

CONTACT

86-021-22200000; jysun1976@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Respiratory Endoscopy

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

CN (1)