The First Affiliated Hospital of Nanchang University
Phase
Not applicable
Started
2024-12-28
Last updated
2025-08-22
Condition(s) studied
Lung NodulesBiopsyNavigation, Spatial
Investigational drug(s) / intervention(s)
Robot-Assisted Bronchoscopy (RAB)
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
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥18 years old, and ≤75 years old, male or female;
2. Patients with peripheral lung lesions found by chest CT, whose diameter ≥ 6mm and \< 3cm, who plan to undergo robotic-assisted bronchoscopic for pulmonary biopsy;
3. The patient voluntarily undergo bronchoscopy and meet the requirements for bronchoscopy;
4. 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.
Exclusion Criteria:
1. Patients with cardiovascular diseases, such as blood pressure instability, myocardial infarction or arrhythmia;
2. Patients with massive hemoptysis within two weeks;
3. Patients with severe pneumothorax and rib fracture;
4. Patients with serious infectious diseases, such as tuberculosis or AIDS;
5. Patients with severe abdominal aortic aneurysm or thoracic aortic aneurysm;
6. 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;
7. Those who were not considered suitable for inclusion by the researchers.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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