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

NCT ID: NCT04106453

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-14

Study Completion Date

2020-02-04

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cancer Surgery Navigation, Spatial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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navigated microwave ablation

microwave ablation is performed laparoscopically with navigation

Group Type EXPERIMENTAL

navigated microwave ablation

Intervention Type PROCEDURE

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

ultrasound guided microwave ablation

microwave ablation is performed laparoscopically with ultrasound guidance

Group Type ACTIVE_COMPARATOR

ultrasound guided navigation

Intervention Type PROCEDURE

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

Interventions

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navigated microwave ablation

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

Intervention Type PROCEDURE

ultrasound guided navigation

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* non
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Köln

OTHER

Sponsor Role lead

Responsible Party

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Roger Wahba, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roger Wahba, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Cologne, , Germany

Site Status

Countries

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Germany

Other Identifiers

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19-392

Identifier Type: -

Identifier Source: org_study_id

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