Identification of Liver Tumours Using BIP - Biopsy System
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|ClinicalTrials.gov Identifier: NCT02620228|
Recruitment Status : Completed
First Posted : December 2, 2015
Last Update Posted : November 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Liver Biopsy||Device: BIP Biopsy System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||INJ-LIVERB-01 Identification of Liver Tumours Using BIP - Biopsy System|
|Actual Study Start Date :||June 9, 2016|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||November 2018|
Experimental: BIP Biopsy System
Biopsy system that enables real-time bioimpedance measurement from the tip of the biopsy needle.
Device: BIP Biopsy System
BIP Biopsy system is essentially similar as traditional biopsy systems but it enables real-time bioimpedance measurement from the tip of the biopsy needle.
- Difference in mean between measured bioimpedance spectra from tumorous and nontumorous tissue [ Time Frame: During liver biopsy (couple of minutes/patient) ]Liver biopsy is performed in traditional way but with biopsy needle that enables bioimpedance measurement from multiple frequencies (spectrum). Tumorous and nontumorous tissue is measured during ultrasound guided biopsy procedure and the tumorous tissue type is verified by histological biopsy sample analysis. The bioimpedance spectra (impedance and phase angle) are compared with each other and differences in means of the spectra calculated. The data analysis is performed offline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620228
|Helsinki University Hospital, Department of Radiology|
|Helsinki, HUS, Finland, FI-00029|
|Principal Investigator:||Kirsti Numminen, PhD MD||Helsinki University Hospital, Department of Radiology|