Identification of Liver Tumours Using BIP - Biopsy System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02620228|
Recruitment Status : Recruiting
First Posted : December 2, 2015
Last Update Posted : June 6, 2017
|Condition or disease||Intervention/treatment|
|Liver Biopsy||Device: BIP Biopsy System|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||INJ-LIVERB-01 Identification of Liver Tumours Using BIP - Biopsy System|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||December 2017|
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
|Contact: Kirsti Numminen, PhD MD||+358 50 427 firstname.lastname@example.org|
|Helsinki University Hospital, Department of Radiology||Recruiting|
|Helsinki, HUS, Finland, FI-00029|
|Contact: Kirsti Numminen, PhD MD email@example.com|
|Principal Investigator:||Kirsti Numminen, PhD MD||Helsinki University Hospital, Department of Radiology|