Lung NodulesNCT07136961
Efficacy and Safety of Robotic-assisted Bronchoscopy Combined With the ICNVA Strategy in Biopsy of Peripheral Pulmonary Nodules
A study testing Robot-Assisted Bronchoscopy (RAB) in people with Lung Nodules and Biopsy, run by The First Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
To assess the efficacy and safety of robotic-assisted bronchoscopy system (bronchial navigation and positioning device) combined with ICNVA strategy for peripheral pulmonary nodule biopsy through a prospective, single-center, single-arm study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Nodules, Biopsy, Navigation, Spatial
- What is being tested?
- Robot-Assisted Bronchoscopy (RAB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2024to 8 Oct 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, and ≤75 years old, male or female;
- Patients with peripheral lung lesions found by chest CT, whose diameter ≥ 6mm and < 3cm, who plan to undergo robotic-assisted bronchoscopic for pulmonary biopsy;
- The patient voluntarily undergo bronchoscopy and meet the requirements for bronchoscopy;
- Patients can understand the purpose of the trial, have good compliance with the examination and follow-up, voluntarily participate in the clinical trial and sign the informed consent.
Who cannot join
- Patients with cardiovascular diseases, such as blood pressure instability, myocardial infarction or arrhythmia;
- Patients with massive hemoptysis within two weeks;
- Patients with severe pneumothorax and rib fracture;
- Patients with serious infectious diseases, such as tuberculosis or AIDS;
- Patients with severe abdominal aortic aneurysm or thoracic aortic aneurysm;
- Participants who have participated in or are participating in drug clinical trials within 3 months before screening, or have participated in other medical device clinical trials within 30 days;
- Those who were not considered suitable for inclusion by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
About this study
Official title: Efficacy and Safety of Robotic-assisted Bronchoscopy Combined With the ICNVA Strategy in Biopsy of Peripheral Pulmonary Nodules: A Prospective, Single-center, Single-arm Study
To assess the efficacy and safety of robotic-assisted bronchoscopy system (bronchial navigation and positioning device) combined with ICNVA strategy for peripheral pulmonary nodule biopsy through a prospective, single-center, single-arm study.
- Conditions
- Lung Nodules, Biopsy, Navigation, Spatial
- Being tested
- Robot-Assisted Bronchoscopy (RAB)
- Keywords
- bronchial navigation and positioning
- Medical subject headings
- Spatial Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted Bronchoscopy (RAB)Procedure or surgery
- Preoxygenation \& Navigation Registration
- Robotic-Guided Navigation
- Puncture Tunnel Establishment
- Position Verification \& Adjustment Perform confirmatory CT scan to assess tool-nodule relationship: Tool-in-lesion (TIL) : Biopsy tool penetrates nodule Center Strike : Tool tip reaches central 1/3 of nodule (coronal/sagittal/horizontal planes) Tool-touch-lesion : Tool contacts but does not enter nodule
- 4mm deviation : Proceed to biopsy >4mm deviation : Adjust based on operator judgment
- Biopsy \& Rapid Evaluation Obtain tissue samples Conduct ROSE (Rapid On-Site Evaluation) to guide next steps
- Post-Procedure Safety Check Perform postoperative CT to exclude pneumothorax/hemorrhage Maintain identical ventilation settings during imaging and biopsy phases to prevent target shift
| Study group | Role | What they receive |
|---|---|---|
| Robot-Assisted Bronchoscopy (RAB) | Experimental | 1. Preoxygenation \& Navigation Registration
2. Robotic-Guided Navigation
3. Puncture Tunnel Establishment
4. Position Verification \& Adjustment
Perform confirmatory CT scan to assess tool-nodule relationship:
Tool-in-lesion (TIL) : Biopsy tool penetrates nodule Center Strike : Tool tip reaches central 1/3 of nodule (coronal/sagittal/horizontal planes) Tool-touch-lesion : Tool contacts but does not enter nodule
* 4mm deviation : Proceed to biopsy >4mm deviation : Adjust based on operator judgment
5. Biopsy \& Rapid Evaluation Obtain tissue samples Conduct ROSE (Rapid On-Site Evaluation) to guide next steps
6. Post-Procedure Safety Check Perform postoperative CT to exclude pneumothorax/hemorrhage Maintain identical ventilation settings during imaging and biopsy phases to prevent target shift Receives: Procedure: Robot-Assisted Bronchoscopy (RAB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tool-in-lesion rate
Measured: Perioperative/Periprocedural
Secondary outcomes (8)
Center Strike rate
Measured: Perioperative/Periprocedural
Tool-touch-lesion rate
Measured: Perioperative/Periprocedural
Successful diagnosis rate
Measured: Perioperative/Periprocedural
Lesion detection rate
Measured: Perioperative/Periprocedural
Bronchopulmonary hemorrhage rate
Measured: Perioperative/Periprocedural
Pneumothorax rate
Measured: Perioperative/Periprocedural
CT to Body divergence（CTBD）
The difference between the distance from the probe to the center of the target nodule in Robotic-Assisted Bronchoscopy and the actual distance from the probe to the target nodule center in follow-up Computed Tomography
Measured: Perioperative/Periprocedural
Successful operation rate
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start28 Dec 2024
- Primary completion8 Jul 2025
- Study completion8 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NodulesStudies of the same condition, open and under way.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaohua Dai, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136961
- Sponsor's protocol ID
- DSH1
- Status last verified
- Aug 2025
- First submitted
- 9 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- 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 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Robotic-assisted Bronchoscopy Combined With the ICNVA Strategy in Biopsy of Peripheral Pulmonary Nodules: A Prospective, Single-center, Single-arm Study
- ClinicalTrials.gov ID
- NCT07136961
- Acronym / sponsor ID
- DSH1
- Conditions
- Lung Nodules, Biopsy, Navigation, Spatial
- Keywords
- bronchial navigation and positioning
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 28 Dec 2024 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 8 Oct 2025 (estimated)
- First posted
- 22 Aug 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.
To assess the efficacy and safety of robotic-assisted bronchoscopy system (bronchial navigation and positioning device) combined with ICNVA strategy for peripheral pulmonary nodule biopsy through a prospective, single-center, single-arm study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot-Assisted Bronchoscopy (RAB) | Experimental | Procedure: Robot-Assisted Bronchoscopy (RAB)1. Preoxygenation \& Navigation Registration 2. Robotic-Guided Navigation 3. Puncture Tunnel Establishment 4. Position Verification \& Adjustment Perform confirmatory CT scan to assess tool-nodule relationship: Tool-in-lesion (TIL) : Biopsy tool penetrates nodule Center Strike : Tool tip reaches central 1/3 of nodule (coronal/sagittal/horizontal planes) Tool-touch-lesion : Tool contacts but does not enter nodule * 4mm deviation : Proceed to biopsy >4mm deviation : Adjust based on operator judgment 5. Biopsy \& Rapid Evaluation Obtain tissue samples Conduct ROSE (Rapid On-Site Evaluation) to guide next steps 6. Post-Procedure Safety Check Perform postoperative CT to exclude pneumothorax/hemorrhage Maintain identical ventilation settings during imaging and biopsy phases to prevent target shift |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old, and ≤75 years old, male or female;
- Patients with peripheral lung lesions found by chest CT, whose diameter ≥ 6mm and < 3cm, who plan to undergo robotic-assisted bronchoscopic for pulmonary biopsy;
- The patient voluntarily undergo bronchoscopy and meet the requirements for bronchoscopy;
- Patients can understand the purpose of the trial, have good compliance with the examination and follow-up, voluntarily participate in the clinical trial and sign the informed consent.
Key exclusion criteria (7 listed)
- Patients with cardiovascular diseases, such as blood pressure instability, myocardial infarction or arrhythmia;
- Patients with massive hemoptysis within two weeks;
- Patients with severe pneumothorax and rib fracture;
- Patients with serious infectious diseases, such as tuberculosis or AIDS;
- Patients with severe abdominal aortic aneurysm or thoracic aortic aneurysm;
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 |
|---|---|---|
| Robot-Assisted Bronchoscopy (RAB)1. Preoxygenation \& Navigation Registration 2. Robotic-Guided Navigation 3. Puncture Tunnel Establishment 4. Position Verification \& Adjustment Perform confirmatory CT scan to assess tool-nodule relationship: Tool-in-lesion (TIL) : Biopsy tool penetrates nodule Center Strike : Tool tip reaches central 1/3 of nodule (coronal/sagittal/horizontal planes) Tool-touch-lesion : Tool contacts but does not enter nodule * 4mm deviation : Proceed to biopsy >4mm deviation : Adjust based on operator judgment 5. Biopsy \& Rapid Evaluation Obtain tissue samples Conduct ROSE (Rapid On-Site Evaluation) to guide next steps 6. Post-Procedure Safety Check Perform postoperative CT to exclude pneumothorax/hemorrhage Maintain identical ventilation settings during imaging and biopsy phases to prevent target shift | Procedure or surgery | Robot-Assisted Bronchoscopy (RAB) |
Primary outcome
Tool-in-lesion rate
Time frame: Perioperative/Periprocedural
8 secondary outcomes
Center Strike rate
Time frame: Perioperative/Periprocedural
Tool-touch-lesion rate
Time frame: Perioperative/Periprocedural
Successful diagnosis rate
Time frame: Perioperative/Periprocedural
Lesion detection rate
Time frame: Perioperative/Periprocedural
Bronchopulmonary hemorrhage rate
Time frame: Perioperative/Periprocedural
Pneumothorax rate
Time frame: Perioperative/Periprocedural
CT to Body divergence（CTBD）
Time frame: Perioperative/Periprocedural
Successful operation rate
Time frame: Perioperative/Periprocedural
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 22 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Lung Nodules
Active, not recruiting
Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules
Lung Cancer, Lung; Node
Recruiting
Longitudinal AI-Assisted Management of Indeterminate Pulmonary Nodules
Pulmonary Nodules, Lung Neoplasms
Active, not recruitingObservational study
Clinical Application of Artificial Intelligence Methods in Diagnostic Imaging of Pulmonary Nodules
Pulmonary Nodules, Lung Neoplasms
RecruitingObservational study
Study of Collection and Analysis of Clinical, Anamnestic, Functional, Biological Data Through the Support of Artificial Intelligence to Evaluate the Possibility of Defining a Digital Twin of the Lung (LUCE)
Thoracic Neoplasm, Pulmonary Nodules
RecruitingObservational study
Lung Cancer Detection in Never Smokers Using Urine Volatile Organic Compound (VOCs)
Lung Cancer
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-Assisted Bronchoscopy (RAB) in people with Lung Nodules and Biopsy, run by The First Affiliated Hospital of Nanchang University 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 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: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tool-in-lesion rate (time frame: Perioperative/Periprocedural). 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 22 Aug 2025.