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NCT04106453

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

Completed NA Last updated 5 February 2020
What this trial tests

NA trial testing navigated microwave ablation in Liver Cancer in 4 participants. Completed in 4 February 2020.

Timeline
14 September 2019
Primary endpoint
14 January 2020
4 February 2020

Quick facts

Lead sponsorUniversitätsklinikum Köln
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposeother
Enrollment4
Start date14 September 2019
Primary completion14 January 2020
Estimated completion4 February 2020
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Universitätsklinikum Köln — full company profile →

Who can join

Eligibility, any sex, with Liver Cancer or Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Navigated laparoscopic microwave ablation of tumour mimics in pig livers: a randomized ex-vivo experimental trial.
    Thomas MN, Dieplinger G, Datta RR, Kleinert R, et al · · 2021 · cited 1× · PMID 33289054 · DOI 10.1007/s00464-020-08180-5

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Other recruiting trials for Liver Cancer

Currently open trials in the same condition.

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Data sources for this page

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