Status:
NOT_YET_RECRUITING
Validate the Safety and Feasibility of the CT-guided Interventional Robot in Percutaneous Lung Cryablation Procedures
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Collaborating Sponsors:
Wuhan United Imaging Surgical co., ltd.
Conditions:
Lung Cancer
Thoracic Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 c...
Detailed Description
Lung cancer is the leading cause of morbidity and mortality of malignant tumors. The surgical resection of lung lobes is the standard treatment for stage I non-small cell lung cancer (NSCLC), with pr...
Eligibility Criteria
Inclusion
- 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
- 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;
- 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;
- Allergy to contrast media or anesthetics;
- Pregnant or breastfeeding women, or those who plan to have children during the clinical study;
- Participants with known addiction to drugs, alcohol, etc.;
- Participants with psychiatric disorders who have no self-control and are unable to communicate clearly;
- 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;
- Any other conditions that the investigator deems unsuitable for participation in this clinical study.
Key Trial Info
Start Date :
September 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06581107
Start Date
September 15 2024
End Date
February 28 2025
Last Update
September 3 2024
Active Locations (1)
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1
Tianjin Medical University, Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060