University of Cologne, Department of General, Visceral and Cancer Surgery
Cologne, 50931, Germany
NCT Number: NCT04106453
In primary and secondary liver tumors microwave ablation could be an alternative to surgical resection.It could be performed laparoscopically. Under ultrasound control the microwave device is placed in the tumor.Therefore spatial orientation is challenging: the tumor is often missed and the failure rate is high. During learning curve this could lead to incomplete tumor ablation and high rate of local recurrence. Targeting systems could optimize that. The CasOne-SPOT-system is an innovative electromagnetic tracking and navigation system for laparoscopic microwave ablation. In this study targeting precision using the SPOT-System should be compared to conventional laparoscopic ultrasound-guided microwave ablation. Therefore tumor mimics (1-2cm) will be created in ex-vivo pig livers and microwave ablation will be performed ultrasound guided or ultrasound navigated. The ablation procedures will be performed by two novices and two experienced surgeons. Aim of this trial is to is to evaluate, if laparoscopic microwave ablation could be facilitated by the use of the SPOT-navigation system.
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Interventional
Not applicable
Cologne, 50931, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
board certified surgeon with experienced liver surgery with/ without experience in laparoscopic microwave ablation
Exclusion criteria
the laparoscopic microwave ablation in the pig liver is performed with the CasOne-Spot system
the laparoscopic microwave ablation iin the pic liver is performed with ultrasound guidance
Time frame: 0-10 minutes
time from beginning of the targeting process until to complete ablation of the tumor mimic
Time frame: up to 1 day
the tumor in relation to the ablation figure is measures and the and and the completeness of the microwave ablation is evaluated
Universitätsklinikum Köln
Other
Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Single Center Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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