Peripheral Pulmonary NodulesNCT06719687
Sd-RAB for the Diagnosis of PPNs
A study testing Self-driving robotic-assisted bronchoscope in people with Peripheral Pulmonary Nodules, run by Shanghai Chest Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Pulmonary Nodules
- What is being tested?
- Self-driving robotic-assisted bronchoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
About this study
Official title: Self-driving Robotic-assisted Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules
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.
Read the detailed 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 nodules.
- Conditions
- Peripheral Pulmonary Nodules
- Being tested
- Self-driving robotic-assisted bronchoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-driving robotic-assisted bronchoscopeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Self-driving robotic-assisted bronchoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (6)
Diagnostic yield
A procedure is deemed diagnostic if a specific benign or malignant diagnosis is made.
Measured: 1 month
Rate of rEBUS confirmation
rEBUS confirmation is defined as visualization of target lesion using rEBUS during the procedure.
Measured: During the procedure
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.
Measured: During the procedure
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.
Measured: During the procedure
Duration of finding lesions
Duration of finding lesions is defined from the insertion of the ultrasound probe to the withdrawal of the ultrasound probe.
Measured: During the procedure
Complication rate
The complications refer to the total of device or procedure related adverse events during or within 1 month after the operation.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Pulmonary NodulesStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, Study director, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719687
- Sponsor's protocol ID
- KS24054
- Status last verified
- Jun 2026
- First submitted
- 3 Dec 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-driving Robotic-assisted Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT06719687
- Acronym / sponsor ID
- KS24054
- Conditions
- Peripheral Pulmonary Nodules
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 nodules.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with peripheral pulmonary nodules | Experimental | Device: Self-driving robotic-assisted bronchoscope30 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-driving robotic-assisted bronchoscopeAll 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. | Device | Patients with peripheral pulmonary nodules |
Primary outcome
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.
6 secondary outcomes
Diagnostic yield
Time frame: 1 month
Rate of rEBUS confirmation
Time frame: During the procedure
Total examination time
Time frame: During the procedure
Navigation time
Time frame: During the procedure
Duration of finding lesions
Time frame: During the procedure
Complication rate
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiayuan Sun study director
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-driving robotic-assisted bronchoscope in people with Peripheral Pulmonary Nodules, run by Shanghai Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayuan Sun, MD, PhD (86-021-22200000 ext. 1511, jysun1976@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Navigation success rate (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.