Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT06581107

Validate the Safety and Feasibility of the CT-guided Interventional Robot in Percutaneous Lung Cryablation Procedures

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

This study aims to investigate whether the interventional robot can be well and safely used for percutaneous lung cryoablation in patients with lung cancer. The robot allows radiologists to remotely control the needle insertion process under CT fluoroscopy guidance. The main questions this study aims to answer are: 1. Whether the robot-assisted Cryoablation method can achieve complete the coverage of preoperatively planned ablation areas; 2. Whether the robot-assisted Cryoablation method can improve the success rate for radiologists to insert the needle into the target lesion area without additional needle adjustment; 3. Whether the robot-assisted Cryoablation method can reduce puncture time, ablation time and procedure time; 4. Whether the robot-assisted Cryoablation method can decrease the patient's complication occurrence rate; 5. Whether the robot-assisted Cryoablation method can obtain decent Evaluation of system performance.

Official title: Validate the Feasibility and Safety of the Robot System by Investgating the CT-fluoroscopy Guidance in Percutaneous Lung Cryablation Procedures of Participants With Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-09-15

Completion Date

2025-02-28

Last Updated

2024-09-03

Healthy Volunteers

Conditions

Lung Cancer Thoracic Cancer

Interventions

PROCEDURE

CT-fluoroscopy guided master-slave intervetional robot-assisted lung Cryoablation

During the procedure, the participants first undergo a CT scan. The radiologist plans the trajectories based on the registered preoperative CECT (contrast-enhanced computed tomography) and intraoperative CT. All participants then undergo navigation, localization, and establishment of cryoprobe trajectories using the interventional master-slave system. On the day of the procedure, the number of needle adjustments, number of cryoprobes used, puncture time, ablation time, and procedure time are recorded. The performance of the research device is evaluated by the radiologists. Postoperative complications of the participants are recorded 7±1 days postoperatively/on the day of discharge based on the postoperative CT scan (whichever comes first).

Inclusion Criteria: 1. Participants suffering from lung cancer and judged by the investigator to be indicated for cryoablation procedures; 2. Participants voluntarily participate in this clinical study and sign the informed consent form; 3. Participants cannot undergo surgical treatment due to contraindications to surgical resection of lung cancer; 4. Participants can understand the study and cooperate with the study procedures, and are able to carry out follow-up observation as required. Exclusion Criteria: 1. Participants have diffuse lesions in both lungs that cannot be improved by ablative therapy; 2. Participants suffer from extensive pleural metastases with massive pleural effusion; 3. Participants have tumors adjacent to the mediastinal blood vessels, contrast allergy, or inability to cooperate, which makes it difficult to choose the route of needle insertion; 4. Participants with lesions encircling blood vessels where ablation may lead to severe bleeding; 5. Participants with severely impaired lung function, with maximal ventilation \<40%; 6. Participants with a low platelet count and severe coagulation abnormalities who cannot tolerate the procedure (anticoagulant therapy and/or anticoagulant medication should be discontinued for more than 1 week prior to ablation therapy); 7. Participants with poor general condition (multiple metastases throughout the body, severe infections, high fever), obvious malignant disease, severe insufficiency of vital organ function, severe anemia, and disorders of nutritional metabolism that cannot be improved in the short term; 8. Allergy to contrast media or anesthetics; 9. Pregnant or breastfeeding women, or those who plan to have children during the clinical study; 10. Participants with known addiction to drugs, alcohol, etc.; 11. Participants with psychiatric disorders who have no self-control and are unable to communicate clearly; 12. Participants who have participated in other drug, biologic, or medical device clinical studies without meeting the primary study endpoint timeframe prior to enrollment in this study; 13. Any other conditions that the investigator deems unsuitable for participation in this clinical study.

Locations (1)

Tianjin Medical University, Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China