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

Not Applicable

Active, not recruiting

• Conditions: Lung Nodules; Biopsy; Navigation, Spatial

• Registration Number: NCT07136961
• Lead Sponsor: The First Affiliated Hospital of Nanchang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-28
• Primary Completion: 2025-07-08
• Status Verified: 2025-08
• Study First Submitted: 2025-08-09
• Study First Submitted QC: 2025-08-15
• Last Update Submitted: 2025-08-15
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Study Completion: 2025-10-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Tool-in-lesion rate	Perioperative/Periprocedural

Secondary Outcome Measures

Name	Time	Method
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
Pneumothorax rate	Perioperative/Periprocedural
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

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China