Validate the Safety and Feasibility of the CT-guided Interventional Robot in Percutaneous Lung Cr… (NCT06581107) | Clinical Trial Compass
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Validate the Safety and Feasibility of the CT-guided Interventional Robot in Percutaneous Lung Cryablation Procedures
China20 participantsStarted 2024-09-15
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Participants suffering from lung cancer and judged by the investigator to be indicated for cryoablation procedures;
✓. Participants voluntarily participate in this clinical study and sign the informed consent form;
✓. Participants cannot undergo surgical treatment due to contraindications to surgical resection of lung cancer;
✓. Participants can understand the study and cooperate with the study procedures, and are able to carry out follow-up observation as required.
Exclusion criteria
✕. Participants have diffuse lesions in both lungs that cannot be improved by ablative therapy;
✕. Participants suffer from extensive pleural metastases with massive pleural effusion;
✕. 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;
✕. Participants with lesions encircling blood vessels where ablation may lead to severe bleeding;
What they're measuring
1
Technical success rate
Timeframe: The day of the procedure
Trial details
NCT IDNCT06581107
SponsorTianjin Medical University Cancer Institute and Hospital
✕. Participants with severely impaired lung function, with maximal ventilation \<40%;
✕. 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);
✕. 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;