Trials / Completed
CompletedNCT04106453
Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Trial
Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Single Center Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Universitätsklinikum Köln · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | navigated microwave ablation | the laparoscopic microwave ablation in the pig liver is performed with the CasOne-Spot system |
| PROCEDURE | ultrasound guided navigation | the laparoscopic microwave ablation iin the pic liver is performed with ultrasound guidance |
Timeline
- Start date
- 2019-09-14
- Primary completion
- 2020-01-14
- Completion
- 2020-02-04
- First posted
- 2019-09-27
- Last updated
- 2020-02-05
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04106453. Inclusion in this directory is not an endorsement.