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

February 4, 2020 updated by: Roger Wahba, MD, PhD, Universitätsklinikum Köln

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, 50931
        • University of Cologne, Department of General, Visceral and Cancer Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • non

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: navigated microwave ablation
microwave ablation is performed laparoscopically with navigation
Procedure: navigated microwave ablation
the laparoscopic microwave ablation in the pig liver is performed with the CasOne-Spot system
ACTIVE_COMPARATOR: ultrasound guided microwave ablation
microwave ablation is performed laparoscopically with ultrasound guidance
Procedure: ultrasound guided navigation
the laparoscopic microwave ablation iin the pic liver is performed with ultrasound guidance

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Köln

Investigators

  • Principal Investigator: Roger Wahba, MD, PhD, General, Visceral, Cancer and Transplant Surgery, University of Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 14, 2019

Primary Completion (ACTUAL)

January 14, 2020

Study Completion (ACTUAL)

February 4, 2020

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (ACTUAL)

September 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-392

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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