Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2024-12-31
2025-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients with peripheral pulmonary lesions
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.
Self-driving robotic-assisted bronchoscope
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.
Interventions
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Self-driving robotic-assisted bronchoscope
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Shanghai Chest Hospital
OTHER
Responsible Party
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Jiayuan Sun
Director, Department of Respiratory Endoscopy
Principal Investigators
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Jiayuan Sun
Role: STUDY_DIRECTOR
Shanghai Chest Hospital
Locations
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Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Other Identifiers
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KS24054
Identifier Type: -
Identifier Source: org_study_id