Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Trial
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 14, 2019
CompletedFirst Submitted
Initial submission to the registry
September 24, 2019
CompletedFirst Posted
Study publicly available on registry
September 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2020
CompletedFebruary 5, 2020
February 1, 2020
4 months
September 24, 2019
February 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to complete ablation
time from beginning of the targeting process until to complete ablation of the tumor mimic
0-10 minutes
Secondary Outcomes (1)
ablation completeness
up to 1 day
Study Arms (2)
navigated microwave ablation
EXPERIMENTALmicrowave ablation is performed laparoscopically with navigation
ultrasound guided microwave ablation
ACTIVE COMPARATORmicrowave ablation is performed laparoscopically with ultrasound guidance
Interventions
the laparoscopic microwave ablation in the pig liver is performed with the CasOne-Spot system
the laparoscopic microwave ablation iin the pic liver is performed with ultrasound guidance
Eligibility Criteria
You may qualify if:
- board certified surgeon with experienced liver surgery with/ without experience in laparoscopic microwave ablation
You may not qualify if:
- non
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Cologne, Department of General, Visceral and Cancer Surgery
Cologne, 50931, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roger Wahba, MD, PhD
General, Visceral, Cancer and Transplant Surgery, University of Cologne
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 24, 2019
First Posted
September 27, 2019
Study Start
September 14, 2019
Primary Completion
January 14, 2020
Study Completion
February 4, 2020
Last Updated
February 5, 2020
Record last verified: 2020-02