Liver CancerNCT04106453
Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Trial
A study testing navigated microwave ablation and ultrasound guided navigation in people with Liver Cancer and Surgery, run by Universitätsklinikum Köln at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cancer, Surgery, Navigation, Spatial
- What is being tested?
- navigated microwave ablation and ultrasound guided navigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteGermany
- Study dates
- 14 Sep 2019to 4 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- board certified surgeon with experienced liver surgery with/ without experience in laparoscopic microwave ablation
Who cannot join
- non
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Cologne, Department of General, Visceral and Cancer Surgery
Cologne, 50931
About this study
Official title: Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Single Center Trial
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
- Liver Cancer, Surgery, Navigation, Spatial
- Being tested
- navigated microwave ablation, ultrasound guided navigation
- Keywords
- laparoscopy, navigation, microwave ablation, ultrasound guidance
- Medical subject headings
- Liver Neoplasms, Spatial Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
navigated microwave ablationProcedure or surgery
the laparoscopic microwave ablation in the pig liver is performed with the CasOne-Spot system
ultrasound guided navigationProcedure or surgery
the laparoscopic microwave ablation iin the pic liver is performed with ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| navigated microwave ablation | Experimental | microwave ablation is performed laparoscopically with navigation Receives: Procedure: navigated microwave ablation |
| ultrasound guided microwave ablation | Active comparator | microwave ablation is performed laparoscopically with ultrasound guidance Receives: Procedure: ultrasound guided navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to complete ablation
time from beginning of the targeting process until to complete ablation of the tumor mimic
Measured: 0-10 minutes
Secondary outcomes (1)
ablation completeness
the tumor in relation to the ablation figure is measures and the and and the completeness of the microwave ablation is evaluated
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start14 Sep 2019
- Primary completion14 Jan 2020
- Study completion4 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Köln
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roger Wahba, MD, PhD, Universitätsklinikum Köln
- Investigators
- Roger Wahba, MD, PhD, Principal investigator, General, Visceral, Cancer and Transplant Surgery, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106453
- Sponsor's protocol ID
- 19-392
- Status last verified
- Feb 2020
- First submitted
- 24 Sep 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Single Center Trial
- ClinicalTrials.gov ID
- NCT04106453
- Acronym / sponsor ID
- 19-392
- Conditions
- Liver Cancer, Surgery, Navigation, Spatial
- Keywords
- laparoscopy, navigation, microwave ablation, ultrasound guidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Universitätsklinikum KölnUniversity, hospital or other
- Study start
- 14 Sep 2019 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| navigated microwave ablation | Experimental | Procedure: navigated microwave ablationmicrowave ablation is performed laparoscopically with navigation |
| ultrasound guided microwave ablation | Active comparator | Procedure: ultrasound guided navigationmicrowave ablation is performed laparoscopically with ultrasound guidance |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- board certified surgeon with experienced liver surgery with/ without experience in laparoscopic microwave ablation
Key exclusion criteria (1 listed)
- non
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| navigated microwave ablationthe laparoscopic microwave ablation in the pig liver is performed with the CasOne-Spot system | Procedure or surgery | navigated microwave ablation |
| ultrasound guided navigationthe laparoscopic microwave ablation iin the pic liver is performed with ultrasound guidance | Procedure or surgery | ultrasound guided microwave ablation |
Primary outcome
time to complete ablation
Time frame: 0-10 minutes
time from beginning of the targeting process until to complete ablation of the tumor mimic
1 secondary outcome
ablation completeness
Time frame: up to 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Wahba, MD, PhD principal investigator
General, Visceral, Cancer and Transplant Surgery, University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing navigated microwave ablation and ultrasound guided navigation in people with Liver Cancer and Surgery, run by Universitätsklinikum Köln at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to complete ablation (time frame: 0-10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.