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The Percutaneous Interventional Surgery Control System for Pulmonary Nodule Biopsy
NCT07277088 · Jiayuan Sun · Updated 11 Dec 2025
- What is being tested
- Percutaneous Needle Biopsy with Interventional Surgical Control System; Conventional Manual Percutaneous Needle Biopsy
- For
- Pulmonary Nodules; Lung Cancer (Diagnosis); Percutaneous Needle Biopsy; Transthoracic Needle Biopsy; Robotic Assisted Intervention
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years to 80 years. About 158 people. The full rules are on the registry page.
- Where
- China
- When
- Starts or started 10 Dec 2025, ends 30 May 2027. Registered 11 Dec 2025.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- Shanghai Chest HospitalShanghai, China