NCT06762613

Functional Innovation and Application Research of Domestic Advanced Low-Dose DSA/CT-DSA

Enhancing CBCT-Guided Lung Nodule Puncture Efficiency With Generative AI

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if Generative AI Based Puncture Surgery Navigation System (GPS) can guide lung puncture in adults better. It will also learn about the quality improvement of cone beam CT (CBCT) by GPS. The main questions it aims to answer are: * Does GPS lower the number of punctures, radiation dose, and complications of participants undergo percutaneous lung puncture? * Does GPS improve the quality of CBCT images? Researchers will compare GPS to a conventional CBCT guided percutaneous lung puncture to see if GPS can improve the efficacy of lung puncture. Participants will: * Take the percutaneous lung puncture by the guidance of GPS or conventional CBCT (placebo) * The number of punctures, the success rate of the procedure, the radiation dose, intraoperative complications and postoperative complications at 7 days will be recorded * The images of CBCT will be collected

Conditions

• Lung Nodules

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Generative AI Based Puncture Surgery Navigation System	Participants will receive percutaneous lung puncture under the guidance of GPS.
DEVICE	Cone beam CT	Participants will receive percutaneous lung puncture under the guidance of cone beam CT.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-03-31
• Completion: 2025-06-18
• First posted: 2025-01-07
• Last updated: 2025-07-23

Locations

3 sites across 1 country: China