Clinical trial · Interventional
Validate the Safety and Feasibility of the CT-guided Interventional Robot in Percutaneous Lung Cryablation Procedures
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Thoracic Cancer | Malignant Thoracic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT-fluoroscopy guided master-slave intervetional robot-assisted lung Cryoablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Singel arm
- description
- CT-fluoroscopy guided robot-assisted percutaneous lung Cryoablation group
- interventionNames
- Procedure: CT-fluoroscopy guided master-slave intervetional robot-assisted lung Cryoablation
Primary outcomes (1)
- measure
- Technical success rate
- timeFrame
- The day of the procedure
- description
- After the cryoablation procedure, the radiologists evaluate the consistency of the postoperative ablation area derived from the immediate postoperative thoracic CT scan with the size of the preoperative planning area. If consistent, it is defined as a technical success. The technical success rate is defined as the ratio of the number of participants with technical success to the total number of enrolled participants.
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available