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

NCT ID: NCT07136961

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-28
• Study Completion Date: 2025-10-08

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.

Conditions

Lung Nodules; Biopsy; Navigation, Spatial

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Robot-Assisted Bronchoscopy (RAB)

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: lead

Responsible Party

Shaohua Dai

M.D., Ph.D, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Countries

China

Other Identifiers

DSH1

Identifier Type: -

Identifier Source: org_study_id