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Tracking of liver metastases during surgery

Completed
Conditions
Open liver surgery, resection margins, surgical navigation
Registration Number
NL-OMON25239
Lead Sponsor
The Netherlands Cancer Institute –Antoni van Leeuwenhoek Hospital
Brief Summary

Electromagnetic tracking of liver tumors during open surgical resections O. Ivashchenko, B. Pouw, K. F. Kuhlmann , R. van Veen, N. F. Kok, E. G. Klompenhouwer, N. Hoetjes, H. C. Groen, J. Nijkamp and TJM Ruers. SPIE Medical Imaging 2019, Conference 10951 – Image-Guided Procedures, Robotic Interventions, and Modeling, 17-21 February 2019, San Diego, USA Intraoperative electromagnetic navigation towards liver tumors: a feasibility study O. Ivashchenko, B. Pouw, R. van Veen, K. F. Kuhlmann, N. F. Kok, E. G. Klompenhouwer, H. C. Groen, J. Nijkamp, TJM Ruers. Computer Assisted Radiology and Surgery (CARS) Conference 2018, 20-23 June, Berlin, Germany In vivo identification of liver tumors during liver surgery using electromagnetic navigation: a pilot study O. Ivashchenko, B. Pouw, J. Nijkamp, K. F.D. Kuhlmann, N. F.M. Kok, E. G. Klompenhouwer, T.J.M. Ruers Conference of the International Society for Medical Innovation and Technology (iSMIT) 2017, 9-10 November 2017, Turin, Italy.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
53
Inclusion Criteria

The study population exists of patients scheduled for surgery of liver metastases from any origin.
In order to be eligible to participate in this study, a subject must meet all of the following criteria:

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

 Metal implants in the abdominal or thorax area that could influence EM tracking or other influences that would influence the EM field.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The main study endpoint is the accuracy of the EM navigation system to measure the distance from the EM probe (or tumor resection margin) to tumor tissue. In addition we will evaluate the handling of the navigation system during liver surgery.
Secondary Outcome Measures
NameTimeMethod
Intuitiveness of the navigation system: this will be evaluated by standardized utility questionnaires.<br /><br>The outcome will be a quantitative value of the intuitiveness of this device which we can compare with other device trials.
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