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The Percutaneous Interventional Surgery Control System for Pulmonary Nodule Biopsy
This prospective, single-center, non-inferiority, randomized controlled clinical trial aims to evaluate the efficacy and safety of a percutaneous interventional surgical control system in performing percutaneous needle biopsy of pulmonary nodules, compared with conventional manual biopsy. The study will be conducted at Shanghai Chest Hospital and plans to enroll 158 patients who meet the indications for percutaneous transthoracic needle biopsy (PTNB) and have no contraindications. Participants will be randomly assigned to one of two groups: the experimental group will undergo PTNB assisted by the percutaneous interventional surgical control system, while the control group will receive traditional manual PTNB. The primary endpoint is diagnostic yield; secondary endpoints include technical success rate, number of needle adjustments, puncture time, total procedure time, radiation dose, and complication rates.
Details
| Lead sponsor | Jiayuan Sun |
|---|---|
| Phase | NA |
| Status | NOT_YET_RECRUITING |
| Enrolment | 158 |
| Start date | Wed Dec 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sun May 30 2027 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Pulmonary Nodules
- Lung Cancer (Diagnosis)
- Percutaneous Needle Biopsy
- Transthoracic Needle Biopsy
- Robotic Assisted Intervention
Interventions
- Percutaneous Needle Biopsy with Interventional Surgical Control System
- Conventional Manual Percutaneous Needle Biopsy
Countries
China