NCT03005756

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

January 25, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

2.1 years

First QC Date

December 26, 2016

Last Update Submit

September 6, 2018

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

  • Total radiation exposure (DLP, mGy*cm)

    Sum of radiation exposures measured during the radiofrequency ablation

    At time of radiofrequency ablation

Secondary Outcomes (3)

  • Number of repositioning of radiofrequency electrode

    At time of radiofrequency ablation

  • Targeting error

    At time of the 1st insertion of the electrode

  • Procedure time

    At time of radiofrequency ablation

Study Arms (1)

Robot-assisted Radiofrequency Ablation

EXPERIMENTAL

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

Device: Needle guiding robot

Interventions

Needle guiding robotDEVICE

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.

Robot-assisted Radiofrequency Ablation

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Related Publications (3)

  • 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.

    PMID: 24220755BACKGROUND

  • 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.

    PMID: 23928933BACKGROUND

  • 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.

    PMID: 25189152BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Sang Do Lee, MD, PhD

CONTACT

82-2-3010-3013webmaster@amc.seoul.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 26, 2016

First Posted

December 29, 2016

Study Start

January 25, 2017

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

September 10, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)