Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07136961

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Those who were not considered suitable for inclusion by the researchers.

Treatment and study plan

Robot-Assisted Bronchoscopy (RAB)

Procedure
  • Preoxygenation & Navigation Registration
  • Robotic-Guided Navigation
  • Puncture Tunnel Establishment
  • 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
  • Biopsy & Rapid Evaluation Obtain tissue samples Conduct ROSE (Rapid On-Site Evaluation) to guide next steps
  • Post-Procedure Safety Check Perform postoperative CT to exclude pneumothorax/hemorrhage Maintain identical ventilation settings during imaging and biopsy phases to prevent target shift

Primary outcomes

  1. Tool-in-lesion rate

    Time frame: Perioperative/Periprocedural

Secondary outcomes

  1. Center Strike rate

    Time frame: Perioperative/Periprocedural

  2. Tool-touch-lesion rate

    Time frame: Perioperative/Periprocedural

  3. Successful diagnosis rate

    Time frame: Perioperative/Periprocedural

  4. Lesion detection rate

    Time frame: Perioperative/Periprocedural

  5. Bronchopulmonary hemorrhage rate

    Time frame: Perioperative/Periprocedural

  6. Pneumothorax rate

    Time frame: Perioperative/Periprocedural

  7. CT to Body divergence(CTBD)

    Time frame: 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

  8. Successful operation rate

    Time frame: Perioperative/Periprocedural

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Nanchang University

Other

Registry information

Official study title

Efficacy and Safety of Robotic-assisted Bronchoscopy Combined With the ICNVA Strategy in Biopsy of Peripheral Pulmonary Nodules: A Prospective, Single-center, Single-arm Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.