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| Name | Class |
|---|---|
| Ministry of Health & Welfare, Korea | OTHER_GOV |
| Hyundai Heavy Industries | UNKNOWN |
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The needle guiding robot helps targeting of radiofrequency ablation needles by matching computed tomography images and patients' bodies. Actual insertion of needles will be performed by doctors. This study evaluates the safety and efficacy of needle targeting on patients with hepatocellular carcinoma.
A robotic system has been developed that includes a needle-path planning system and a needle-guiding robot arm with computed tomography (CT) guidance. The robot consists of robot base, 5-axis robot arm with guiding end-effector and path-planner. Optical tracking system with a custom-designed registration jig is used for the spatial registration and validation. Advantages of the robotic system would be accurate targeting with diverse angulation of the robot arm in CT-guided tumor ablation. Furthermore, robotic intervention might potentially decrease procedure time and radiation exposure to patients. The purpose of this clinical trial with patients with hepatocelluar carcinoma is to assess the safety and efficacy of our CT-guided needle-guiding robot.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-assisted Radiofrequency Ablation | Experimental | CT-guided radiofrequency ablation of hepatocellular carcinoma using needle guiding robot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Needle guiding robot | Device | This intervention is to evaluate the safety and efficacy of a needle guiding robot for assisting targeting in CT-guided radiofrequency ablation of hepatocelluar carcinomas. |
| Measure | Description | Time Frame |
|---|---|---|
| Total radiation exposure (DLP, mGy*cm) | Sum of radiation exposures measured during the radiofrequency ablation | At time of radiofrequency ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of repositioning of radiofrequency electrode | Number of repositioning of radiofrequency electrode in order to correct targeting discrepancy untile properly placed in to the target tumor | At time of radiofrequency ablation |
| Targeting error |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang Do Lee, MD, PhD | Contact | 82-2-3010-3013 | webmaster@amc.seoul.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24220755 | Background | Koethe Y, Xu S, Velusamy G, Wood BJ, Venkatesan AM. Accuracy and efficacy of percutaneous biopsy and ablation using robotic assistance under computed tomography guidance: a phantom study. Eur Radiol. 2014 Mar;24(3):723-30. doi: 10.1007/s00330-013-3056-y. Epub 2013 Nov 13. | |
| 23928933 | Background | Abdullah BJ, Yeong CH, Goh KL, Yoong BK, Ho GF, Yim CC, Kulkarni A. Robot-assisted radiofrequency ablation of primary and secondary liver tumours: early experience. Eur Radiol. 2014 Jan;24(1):79-85. doi: 10.1007/s00330-013-2979-7. Epub 2013 Aug 9. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Distance between the target and the electrode tip
| At time of the 1st insertion of the electrode |
| Procedure time | Total period of time from the installation of needle guiding robot to patient's transfer after the procedure | At time of radiofrequency ablation |
| 25189152 | Background | Abdullah BJ, Yeong CH, Goh KL, Yoong BK, Ho GF, Yim CC, Kulkarni A. Robotic-assisted thermal ablation of liver tumours. Eur Radiol. 2015 Jan;25(1):246-57. doi: 10.1007/s00330-014-3391-7. Epub 2014 Sep 5. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |