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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04106453
• Other study ID #: 19-392
• Status: Completed
• Phase: N/A
• Start date: September 14, 2019
• Est. completion date: February 4, 2020

Study information

• Verified date: February 2020
• Source: Universitätsklinikum Köln
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: February 4, 2020
• Est. primary completion date: January 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• non

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms
• Navigation, Spatial
• Surgery

Intervention

Procedure:
• navigated microwave ablation
the laparoscopic microwave ablation in the pig liver is performed with the CasOne-Spot system
• ultrasound guided navigation
the laparoscopic microwave ablation iin the pic liver is performed with ultrasound guidance

Locations

Country	Name	City	State
Germany	University of Cologne, Department of General, Visceral and Cancer Surgery	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Köln

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to complete ablation	time from beginning of the targeting process until to complete ablation of the tumor mimic	0-10 minutes
Secondary	ablation completeness	the tumor in relation to the ablation figure is measures and the and and the completeness of the microwave ablation is evaluated	up to 1 day