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OpenTrials
Completed

NCT Number: NCT04106453

Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Trial

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cologne, Department of General, Visceral and Cancer Surgery

Cologne, 50931, Germany

Who can participate

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

  • non

Treatment and study plan

navigated microwave ablation

Procedure

the laparoscopic microwave ablation in the pig liver is performed with the CasOne-Spot system

ultrasound guided navigation

Procedure

the laparoscopic microwave ablation iin the pic liver is performed with ultrasound guidance

Primary outcomes

  1. time to complete ablation

    Time frame: 0-10 minutes

    time from beginning of the targeting process until to complete ablation of the tumor mimic

Secondary outcomes

  1. ablation completeness

    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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Köln

Other

Registry information

Official study title

Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Single Center Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 27, 2019
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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