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Brief Title: Identification of Liver Tumours Using BIP - Biopsy System
Official Title: INJ-LIVERB-01 Identification of Liver Tumours Using BIP - Biopsy System
Study ID: NCT02620228
Brief Summary: This clinical device investigation is conducted by performing liver biopsies using the BIP - Biopsy Tool. The aim is to assess the feasibility of bioimpedance spectroscopy based biopsy tool guidance method and test how well BIP biopsy system is able to distinguish liver tumours from surrounding tissue. In addition, user feedback is obtained to improve the usability of the investigational device. The study does not affect the traditional treatment procedure and only the patients in clinical need for diagnosis by liver biopsy are included on voluntary basis. The invasive products used in actual biopsy operation are designed so that their performance is essentially equal to the currently used biopsy devices, the only difference is the measurement capability of biopsy needle and connection to measurement device.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Helsinki University Hospital, Department of Radiology, Helsinki, HUS, Finland
Name: Kirsti Numminen, PhD MD
Affiliation: Helsinki University Hospital, Department of Radiology
Role: PRINCIPAL_INVESTIGATOR