Peripheral Pulmonary NodulesNCT06962436
RAB Versus Ultrathin Bronchoscopy With VBN in the Diagnosis of PPNs
A study testing Robotic bronchoscopy system and Ultrathin bronchoscope combined with virtual bronchoscopic navigation in people with Peripheral Pulmonary Nodules, run by Shanghai Chest Hospital at 5 sites in China.
Trial summary
The purpose of this study is to evaluate whether the diagnostic yield of robotic-assisted bronchoscopy is not inferior to that of the virtual bronchoscopic navigation combined with ultrathin bronchoscopy. 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?
- Robotic bronchoscopy system and Ultrathin bronchoscope combined with virtual bronchoscopic navigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 5 sitesChina
- Study dates
- 2 Jul 2025to Dec 2026
- 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
- Age ≥ 18 years, regardless of gender;
- Patients with peripheral lung nodules of suspected malignancy on chest CT who require non-surgical biopsy;
- Patients who voluntarily consent to undergo bronchoscopy and meet the requirements for the bronchoscopy;
- Patients should understand the purpose of the trial, demonstrate good compliance with the examinations and follow-ups, and voluntarily participate in the clinical trial and sign the informed consent form.
Who cannot join
- Presence of contraindications for bronchoscopy, including: active massive hemoptysis; recent myocardial infarction or unstable angina; severe cardiac or pulmonary dysfunction; severe hypertension and arrhythmias; uncorrectable bleeding tendencies or severe coagulation disorders (such as platelet count <60×10^9/L), uremia; severe pulmonary artery hypertension; severe superior vena cava syndrome; intracranial hypertension; acute cerebrovascular events; aortic dissection or aneurysm; multiple bullae; extreme systemic exhaustion;
- Patients with pure ground-glass nodules suspected of malignancy on chest CT;
- Female patients who are breastfeeding, pregnant, or planning pregnancy;
- Patients with electromagnetic active implantable medical devices;
- Subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history;
- Those who have participated in or are currently participating in drug clinical trials within 3 months before screening, or have participated in other medical device clinical trials within 30 days;
- Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Enguo Chen, PhD, 0571-87887890, 3195024@zju.edu.cn
- Recruiting
Shandong Public Health Clinical Center
Jinan, Shandong, 250000
Xiaopin Wang, PhD, 86-0531-86568019, jinan5823@126.com
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Wei CHEN, PHD, 021-64370045, cw11242@rjh.com.cn
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Jiayuan Sun, PhD, 86-21-22200000 ext. 1511, jysun1976@163.com
- Recruiting
Zhongshan Hospital，Fudan University
Shanghai, Shanghai Municipality, 200032
Chun Li, MD, 86-21-64041990, li.chun@zs-hospital.sh.cn
About this study
Official title: Robotic-Assisted Bronchoscopy Versus Ultrathin Bronchoscope Combined With Virtual Bronchoscopic Navigation for the Diagnosis of Peripheral Pulmonary Nodules: A Prospective, Multicenter, Randomized Controlled，Non-inferiority Clinical Study
The purpose of this study is to evaluate whether the diagnostic yield of robotic-assisted bronchoscopy is not inferior to that of the virtual bronchoscopic navigation combined with ultrathin bronchoscopy.
Read the detailed description
This is an investigator-initiated, prospective, multicenter, randomized , non-inferiority clinical trial, with a total of 186 participants planned for enrollment. Subjects with peripheral pulmonary nodules (PPNs) suspected of malignancy, requiring non-surgical biopsy detected by chest CT will be included in this study. Firstly, the physician will determine the lesion to be biopsied, then the subject will be randomly assigned to either the experimental or control group. The experimental group will undergo the procedure using the robotic-assisted bronchoscopy system and catheters, developed by Changzhou Langhe Medical Devices Co., Ltd. for the localization and sampling of PPNs. The control group will undergo ultrathin bronchoscopy guided by virtual bronchoscopic navigation. Radial endobronchial ultrasound (r-EBUS) will be available for all procedures. If the physician determines that biopsy sampling is feasible, a transbronchial lung biopsy will be performed. The primary endpoint is the intermediate definition of diagnostic yield. Secondary endpoints include navigation success yield, arrival time, incidence of complications, and strict definition of diagnostic yield.
- Conditions
- Peripheral Pulmonary Nodules
- Being tested
- Robotic bronchoscopy system, Ultrathin bronchoscope combined with virtual bronchoscopic navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic bronchoscopy systemDevice
Utilization of a robotic bronchoscopy system for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy
Ultrathin bronchoscope combined with virtual bronchoscopic navigationDevice
Utilization of ultrathin bronchoscope combined with virtual bronchoscopic navigation for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy
| Study group | Role | What they receive |
|---|---|---|
| RAB group | Experimental | The eligible patient will be diagnosed using the robotic bronchoscopy system and catheters developed by Changzhou Langhe Medical Devices Co., Ltd. Receives: Device: Robotic bronchoscopy system |
| UB-VBN group | Active comparator | The eligible patient will be diagnosed using ultrathin bronchoscope combined with virtual bronchoscopic navigation. Receives: Device: Ultrathin bronchoscope combined with virtual bronchoscopic navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
Intermediate definition of diagnostic yield=(Number of procedures with a specific malignant or benign pathological diagnosis+Number of procedures with nonspecific benign diagnoses that turn out to be nonmalignant at follow-up)/Total number of patients in whom the minimally invasive procedure was attempted or performed*100%
Measured: 14 days post-procedure
Secondary outcomes (4)
Navigation success yield
Navigation success yield = (number of nodules successfully navigated / total number of nodules biopsied by bronchoscopy in each group) * 100%
Measured: During the procedure
Navigation time
In the experimental group, the navigation time is measured from the tracheal carina after the registration to the moment the lesion is visible at the front-end camera of the catheter or confirmed by r-EBUS. In the control group, the navigation time is measured from the tracheal carina to the moment the lesion is confirmed by r-EBUS.
Measured: During the procedure
Incidence of complications
Incidence of complications = (number of cases with complications / total number of sampled cases) * 100%.
Complications are categorized according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and include events such as pneumothorax and bleeding.
Measured: 14 days post-procedure
Strict definition of diagnostic yield
Strict definition of diagnostic yield=(Number of procedures with a specific malignant or benign pathological diagnosis)/Total number of patients in whom the minimally invasive procedure was attempted or performed*100%
Measured: 14 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start2 Jul 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 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
- NCT06962436
- Sponsor's protocol ID
- SHCHE202503
- Status last verified
- Mar 2026
- First submitted
- 30 Apr 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-Assisted Bronchoscopy Versus Ultrathin Bronchoscope Combined With Virtual Bronchoscopic Navigation for the Diagnosis of Peripheral Pulmonary Nodules: A Prospective, Multicenter, Randomized Controlled，Non-inferiority Clinical Study
- ClinicalTrials.gov ID
- NCT06962436
- Acronym / sponsor ID
- SHCHE202503
- Conditions
- Peripheral Pulmonary Nodules
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 May 2025 (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.
The purpose of this study is to evaluate whether the diagnostic yield of robotic-assisted bronchoscopy is not inferior to that of the virtual bronchoscopic navigation combined with ultrathin bronchoscopy.
Detailed description
This is an investigator-initiated, prospective, multicenter, randomized , non-inferiority clinical trial, with a total of 186 participants planned for enrollment. Subjects with peripheral pulmonary nodules (PPNs) suspected of malignancy, requiring non-surgical biopsy detected by chest CT will be included in this study. Firstly, the physician will determine the lesion to be biopsied, then the subject will be randomly assigned to either the experimental or control group. The experimental group will undergo the procedure using the robotic-assisted bronchoscopy system and catheters, developed by Changzhou Langhe Medical Devices Co., Ltd. for the localization and sampling of PPNs. The control group will undergo ultrathin bronchoscopy guided by virtual bronchoscopic navigation. Radial endobronchial ultrasound (r-EBUS) will be available for all procedures. If the physician determines that biopsy sampling is feasible, a transbronchial lung biopsy will be performed. The primary endpoint is the intermediate definition of diagnostic yield. Secondary endpoints include navigation success yield, arrival time, incidence of complications, and strict definition of diagnostic yield.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAB group | Experimental | Device: Robotic bronchoscopy systemThe eligible patient will be diagnosed using the robotic bronchoscopy system and catheters developed by Changzhou Langhe Medical Devices Co., Ltd. |
| UB-VBN group | Active comparator | Device: Ultrathin bronchoscope combined with virtual bronchoscopic navigationThe eligible patient will be diagnosed using ultrathin bronchoscope combined with virtual bronchoscopic navigation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years, regardless of gender;
- Patients with peripheral lung nodules of suspected malignancy on chest CT who require non-surgical biopsy;
- Patients who voluntarily consent to undergo bronchoscopy and meet the requirements for the bronchoscopy;
- Patients should understand the purpose of the trial, demonstrate good compliance with the examinations and follow-ups, and voluntarily participate in the clinical trial and sign the informed consent form.
Key exclusion criteria (7 listed)
- Presence of contraindications for bronchoscopy, including: active massive hemoptysis; recent myocardial infarction or unstable angina; severe cardiac or pulmonary dysfunction; severe hypertension and arrhythmias; uncorrectable bleeding tendencies or severe coagulation disorders (such as platelet count <60×10^9/L), uremia; severe pulmonary artery hypertension; severe superior vena cava syndrome; intracranial hypertension; acute cerebrovascular events; aortic dissection or aneurysm; multiple bullae; extreme systemic exhaustion;
- Patients with pure ground-glass nodules suspected of malignancy on chest CT;
- Female patients who are breastfeeding, pregnant, or planning pregnancy;
- Patients with electromagnetic active implantable medical devices;
- Subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history;
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 |
|---|---|---|
| Robotic bronchoscopy systemUtilization of a robotic bronchoscopy system for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy | Device | RAB group |
| Ultrathin bronchoscope combined with virtual bronchoscopic navigationUtilization of ultrathin bronchoscope combined with virtual bronchoscopic navigation for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy | Device | UB-VBN group |
Primary outcome
Diagnostic yield
Time frame: 14 days post-procedure
Intermediate definition of diagnostic yield=(Number of procedures with a specific malignant or benign pathological diagnosis+Number of procedures with nonspecific benign diagnoses that turn out to be nonmalignant at follow-up)/Total number of patients in whom the minimally invasive procedure was attempted or performed*100%
4 secondary outcomes
Navigation success yield
Time frame: During the procedure
Navigation time
Time frame: During the procedure
Incidence of complications
Time frame: 14 days post-procedure
Strict definition of diagnostic yield
Time frame: 14 days post-procedure
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 Mar 2026.
- Individual participant dataSharing planned: No
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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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic bronchoscopy system and Ultrathin bronchoscope combined with virtual bronchoscopic navigation in people with Peripheral Pulmonary Nodules, run by Shanghai Chest Hospital at 5 sites 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Xiaoxuan Zheng (18930859598, milozheng9140@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: 14 days post-procedure). 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 Mar 2026.