Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety of Robotic-assisted Bronchoscopy Combined With the ICNVA Strategy in Biopsy of Peripheral Pulmonary Nodules
Lead Sponsor:
The First Affiliated Hospital of Nanchang University
Conditions:
Lung Nodules
Biopsy
Eligibility:
All Genders
18-75 years
Phase:
NA
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 pr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07136961
Start Date
December 28 2024
End Date
October 8 2025
Last Update
August 22 2025
Active Locations (1)
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1
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006