CClinicalTrials.gg
Status unknownNCT03005756NGRUpdated Sep 10, 2018

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

An interventional study of Needle guiding robot in Carcinoma, Hepatocellular, sponsored by Asan Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-09-10.

Sponsored by Asan Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
19 Years to 80 Years
Sex
All
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Study summary

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.

Read the detailed description

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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Conditions studied

  • Carcinoma, Hepatocellular
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 20 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with untreatable/unmanageable coagulopathy
  • Patients who are allergic to CT contrast media
  • Patients with vascular invasion or extrahepatic metastases
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Robot-assisted Radiofrequency Ablation

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

    Device: Needle guiding robot

Interventions

  • DeviceNeedle 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.

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What researchers measure

Primary outcomes

  1. Total radiation exposure (DLP, mGy*cm)

    Sum of radiation exposures measured during the radiofrequency ablation

    Time frame: At time of radiofrequency ablation

Secondary outcomes

  1. 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

    Time frame: At time of radiofrequency ablation

  2. Targeting error

    Distance between the target and the electrode tip

    Time frame: At time of the 1st insertion of the electrode

  3. Procedure time

    Total period of time from the installation of needle guiding robot to patient's transfer after the procedure

    Time frame: At time of radiofrequency ablation

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Study locations

1 of 1 sites recruiting
  • Asan Medical Center
    Seoul, 05505, Korea, Republic of
    • Sang Do Lee, MD, PhD · Contact · webmaster@amc.seoul.kr · 82-2-3010-3013
    • Hyung Jin Won, MD, PhD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 24220755 ↗
  • 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. PubMed 23928933 ↗
  • 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. PubMed 25189152 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03005756
Lead sponsor
Asan Medical Center
Collaborators
Ministry of Health & Welfare, Korea, Hyundai Heavy Industries
Responsible party
Hyung Jin Won (Associate Professor, Asan Medical Center) — Principal investigator
First posted
Dec 29, 2016
Start date
Jan 25, 2017
Primary completion
Mar 2019 (estimated)
Completion
Mar 2019 (estimated)
Last update
Sep 10, 2018

Study contacts

Sang Do Lee, MD, PhD
Contact
webmaster@amc.seoul.kr
82-2-3010-3013

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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