Finished
Validate the Safety and Feasibility of the CT-guided Interventional Robot in Percutaneous Biopsy Procedure.
NCT06484764 · Tianjin Medical University Cancer Institute and Hospital · Updated 5 July 2024
- What is being tested
- CT-fluoroscopy guided robot-assisted biopsy of thoracic and abdominal lesions; Freehand CT-guided percutaneous needle biopsy of thoracic and abdominal lesions
- For
- Abdominal Cancer; Thoracic Cancer
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 166 people. The full rules are on the registry page.
- Where
- China (3 sites)
- When
- Starts or started 3 July 2023, ends 24 Nov 2023. Registered 3 July 2024.
- Results
- None posted yet.
In the researchers' words
This multicenter, randomized controlled trial aims to investigate whether the interventional robot can be well and safely used for percutaneous needle biopsy compared with the freehand needle biopsy method under CT guidance in patients with suspected thoracic or abdominal lesions. The robot allows radiologists to remotely control the needle insertion process under the CT-fluoroscopy guidance. The main questions it aims to answer are: 1. Whether the robot-assisted needle biopsy method can decrease patient radiation exposure during the biopsy procedure. 2. Whether the robot-assisted needle biopsy method can improve the success rate for radiologists to insert the needle into the target lesions area without additional needle adjustment 3. Whether the robot-assisted needle biopsy method can decrease the patient's complication occurrence rate 4. Whether the robot-assisted needle biopsy method can decrease the time from the beginning to the end of needle insertion. All the participants with suspected thoracic and abdominal lesions will be randomly assigned to the study group or control group. Participants in the study group will receive a robot-assisted biopsy procedure under the CT-fluoroscopy guidance. Participants in the control group will receive a freehand needle biopsy under the CT guidance.
Sites
- First Clinical Affiliation of Guangzhou Medical UniversityGuangzhou, China
- Tianjin Medical University Cancer Institute and HospitalTianjin, China
- Tongji Hospital of Huazhong University of Science and TechnologyWuhan, China
