Identification of Liver Tumours Using BIP - Biopsy System

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.

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Key information

Conditions

Liver Biopsy Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital, Department of Radiology

Helsinki, HUS, FI-00029, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Consenting adults undergoing ultrasound-guided core liver biopsy to diagnose liver tumour or other abnormalities
Identifiable non-tumorous liver tissue along the planned needle injection path.

Exclusion criteria

Inability to give informed consent
Being under aged
Being pregnant
Being high risk patient
Lack of identifiable non-tumorous liver tissue along the injection path to the tumour location
Known contraindications to liver biopsy.

Treatment and study plan

BIP Biopsy System

Device

BIP Biopsy system is essentially similar as traditional biopsy systems but it enables real-time bioimpedance measurement from the tip of the biopsy needle.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Injeq Ltd

Industry

Registry information

Official study title

INJ-LIVERB-01 Identification of Liver Tumours Using BIP - Biopsy System

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2018
First posted: Dec 2, 2015
Registry last updated: Nov 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed