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

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Aug 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat lung cancer using an advanced robot that helps doctors insert a needle into the lung to freeze and destroy cancer cells, a process called cryoablation. The researchers want to find out if this robot can do the job more accurately and safely than traditional methods. They will look at how well the robot can hit the target area, how quickly the procedure can be done, and if it can lower the chances of complications for patients.

To participate in this study, patients need to have lung cancer and be eligible for cryoablation treatment, but they should not be able to have surgery for some reason. They also need to agree to join the study and be able to follow the instructions provided. This trial is focused on ensuring the safety and effectiveness of this robot-assisted method, so participants can expect close monitoring and support throughout the process. It's important for potential participants to discuss their options with their healthcare providers to see if this trial is a good fit for their situation.

Gender

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Eligibility criteria

• 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.