Needle Guiding Robot for Radiofrequency Ablation: Safety and Efficacy Study on Hepatocellular Carcinoma Patients

NCT ID: NCT03005756

Last Updated: 2018-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-25

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robot-assisted Radiofrequency Ablation

CT-guided radiofrequency ablation of hepatocellular carcinoma using needle guiding robot

Group Type EXPERIMENTAL

Needle guiding robot

Intervention Type 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.

Interventions

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Needle guiding robot

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with up to three Hepatocellular carcinomas (HCC) with no single HCC larger than 3 cm
* Candidates for CT-guided radiofrequency ablation of HCC
* Child-Pugh class A or B

Exclusion Criteria

* Patients with untreatable/unmanageable coagulopathy
* Patients who are allergic to CT contrast media
* Patients with vascular invasion or extrahepatic metastases
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health & Welfare, Korea

OTHER_GOV

Sponsor Role collaborator

Hyundai Heavy Industries

UNKNOWN

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hyung Jin Won

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sang Do Lee, MD, PhD

Role: CONTACT

82-2-3010-3013

Facility Contacts

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Sang Do Lee, MD, PhD

Role: primary

82-2-3010-3013

References

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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.

Reference Type BACKGROUND
PMID: 24220755 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23928933 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25189152 (View on PubMed)

Other Identifiers

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Robin_RFA_01

Identifier Type: -

Identifier Source: org_study_id

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