Efficacy and Safety of Robotic-assisted Bronchoscopy Combined With the ICNVA Strategy in Biopsy of Peripheral Pulmonary Nodules

Nanchang University

Status: Active, not recruiting

Conditions: Biopsy; Navigation, Spatial; Lung Nodules

Treatments: Procedure: Robot-Assisted Bronchoscopy (RAB)

Study type: Interventional

Funder types: Other

Identifiers

NCT07136961

DSH1

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Robot-Assisted Bronchoscopy (RAB)

Experimental group

Description:

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

Treatment:

Procedure: Robot-Assisted Bronchoscopy (RAB)