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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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;
. 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;