Back to resultsNavigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Trial
Primary Purpose
Liver Cancer, Surgery, Navigation, Spatial
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
navigated microwave ablation
ultrasound guided navigation
Sponsored by
About this trial
This is an interventional other trial for Liver Cancer focused on measuring laparoscopy, navigation, microwave ablation, ultrasound guidance
Eligibility Criteria
Inclusion Criteria:
board certified surgeon with experienced liver surgery with/ without experience in laparoscopic microwave ablation
Exclusion Criteria:
- non
Sites / Locations
- University of Cologne, Department of General, Visceral and Cancer Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
navigated microwave ablation
ultrasound guided microwave ablation
Arm Description
microwave ablation is performed laparoscopically with navigation
microwave ablation is performed laparoscopically with ultrasound guidance
Outcomes
Primary Outcome Measures
time to complete ablation
time from beginning of the targeting process until to complete ablation of the tumor mimic
Secondary Outcome Measures
ablation completeness
the tumor in relation to the ablation figure is measures and the and and the completeness of the microwave ablation is evaluated
Full Information
NCT ID
NCT04106453
First Posted
September 24, 2019
Last Updated
February 4, 2020
Sponsor
Universitätsklinikum Köln
1. Study Identification
Unique Protocol Identification Number
NCT04106453
Brief Title
Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Trial
Official Title
Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Single Center Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 14, 2019 (Actual)
Primary Completion Date
January 14, 2020 (Actual)
Study Completion Date
February 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Köln
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Surgery, Navigation, Spatial
Keywords
laparoscopy, navigation, microwave ablation, ultrasound guidance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
navigated microwave ablation
Arm Type
Experimental
Arm Description
microwave ablation is performed laparoscopically with navigation
Arm Title
ultrasound guided microwave ablation
Arm Type
Active Comparator
Arm Description
microwave ablation is performed laparoscopically with ultrasound guidance
Intervention Type
Procedure
Intervention Name(s)
navigated microwave ablation
Intervention Description
the laparoscopic microwave ablation in the pig liver is performed with the CasOne-Spot system
Intervention Type
Procedure
Intervention Name(s)
ultrasound guided navigation
Intervention Description
the laparoscopic microwave ablation iin the pic liver is performed with ultrasound guidance
Primary Outcome Measure Information:
Title
time to complete ablation
Description
time from beginning of the targeting process until to complete ablation of the tumor mimic
Time Frame
0-10 minutes
Secondary Outcome Measure Information:
Title
ablation completeness
Description
the tumor in relation to the ablation figure is measures and the and and the completeness of the microwave ablation is evaluated
Time Frame
up to 1 day
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
board certified surgeon with experienced liver surgery with/ without experience in laparoscopic microwave ablation
Exclusion Criteria:
non
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Wahba, MD, PhD
Organizational Affiliation
General, Visceral, Cancer and Transplant Surgery, University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cologne, Department of General, Visceral and Cancer Surgery
City
Cologne
ZIP/Postal Code
50931
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Trial
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