Health TrialsbyHealthPanel

Sd-RAB for the Diagnosis of PPNs

ConditionPeripheral Pulmonary Nodules
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Chest Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Patients with peripheral pulmonary nodulesExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
1 month

Secondary outcomes

1

Diagnostic yield

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

Time frame
1 month
2

Rate of rEBUS confirmation

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

Time frame
During the procedure
3

Total examination time

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.

Time frame
During the procedure
4

Navigation time

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.

Time frame
During the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Chest Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: