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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04106453

Enrollment

Registered

2019-09-27

Start date

2019-09-14

Completion date

2020-02-04

Last updated

2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer, Navigation, Spatial, Surgery

Keywords

laparoscopy, navigation, microwave ablation, ultrasound guidance

Brief summary

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.

Interventions

PROCEDUREnavigated microwave ablation

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

PROCEDUREultrasound guided navigation

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

board certified surgeon with experienced liver surgery with/ without experience in laparoscopic microwave ablation

Exclusion criteria

* non

Design outcomes

Primary

Measure	Time frame	Description
time to complete ablation	0-10 minutes	time from beginning of the targeting process until to complete ablation of the tumor mimic

Secondary

Measure	Time frame	Description
ablation completeness	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026