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

NCT07136961 | Active Not Recruiting

• 1 other identifier: DSH1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

bronchial navigation and positioning

Outcome Measures

Primary Outcomes (1)

• Tool-in-lesion rate

  Perioperative/Periprocedural

Secondary Outcomes (8)

• Center Strike rate

  Perioperative/Periprocedural

• Tool-touch-lesion rate

  Perioperative/Periprocedural

• Successful diagnosis rate

  Perioperative/Periprocedural

• Lesion detection rate

  Perioperative/Periprocedural

• Bronchopulmonary hemorrhage rate

  Perioperative/Periprocedural

Study Arms (1)

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

Procedure: Robot-Assisted Bronchoscopy (RAB)

Interventions

Robot-Assisted Bronchoscopy (RAB) 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

Robot-Assisted Bronchoscopy (RAB)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital of Nanchang University: lead

Study Sites (1)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

MeSH Terms

Conditions

Spatial Navigation

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D, Professor

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 22, 2025
• Study Start: December 28, 2024
• Primary Completion: July 8, 2025
• Study Completion: October 8, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)