Biopsy, Lung Nodules, Navigation, Spatial
Conditions
Keywords
bronchial navigation and positioning
Brief 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.
Interventions
PROCEDURERobot-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
Sponsors
The First Affiliated Hospital of Nanchang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tool-in-lesion rate | Perioperative/Periprocedural |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CT to Body divergence（CTBD） | Perioperative/Periprocedural | 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 |
| Successful operation rate | Perioperative/Periprocedural | — |
| Center Strike rate | Perioperative/Periprocedural | — |
| Pneumothorax rate | Perioperative/Periprocedural | — |
| Successful diagnosis rate | Perioperative/Periprocedural | — |
| Lesion detection rate | Perioperative/Periprocedural | — |
| Bronchopulmonary hemorrhage rate | Perioperative/Periprocedural | — |
| Tool-touch-lesion rate | Perioperative/Periprocedural | — |
Countries
China
Outcome results
None listed