Status:
COMPLETED
Accuracy Assessment for Computer-assisted Surgical Interventions of the Liver
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Adult Liver Cancer
Eligibility:
All Genders
18+ years
Brief Summary
Preoperative image-guided data correlates with the actual intraoperative reality. Computer-assisted preoperative planning combined with intraoperative mapping of even very small lesions allows for imp...
Detailed Description
Background The aim of this study is to analyze the available accuracy of a computer-assisted approach to liver surgery and microwave ablation. The term 'computer-assisted' refers to 1) using 3D model...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Written informed consent
- Male patients and non-pregnant, non-lactating females aged ≥18 years of age (negative serum/urine pregnancy test result at screening)
- Patients must be candidates for surgical liver resection and/or MWA (at least one anatomical segment) of primary or metastatic liver cancer. The liver tumors must be present on preoperative imaging study (CT and/or MRI).
- Exclusion Criteria
- Any condition which, in the judgment of the clinical investigator or his designee, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
- A mental condition rendering the patient unable to provide informed consent.
- Patients with hereditary hematological / coagulation disorders unrelated to their liver disease or cirrhosis of the liver classified as Child's B or C.
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01474694
Start Date
October 1 2011
End Date
December 1 2013
Last Update
November 26 2015
Active Locations (1)
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1
Dep. of visceral and Transplant Surgery, Bern University Hospital
Bern, Switzerland, 3010