Identification of Liver Tumours Using BIP - Biopsy System

Study Overview
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Brief Summary
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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.

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

Conditions
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Liver Biopsy

Intervention / Treatment
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* Device: BIP Biopsy System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIP Biopsy System<br>Biopsy system that enables real-time bioimpedance measurement from the tip of the biopsy needle. | Device: BIP Biopsy System<br>* BIP Biopsy system is essentially similar as traditional biopsy systems but it enables real-time bioimpedance measurement from the tip of the biopsy needle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in mean between measured bioimpedance spectra from tumorous and nontumorous tissue | 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. | During liver biopsy (couple of minutes/patient) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biopsy, Bioimpedance, Liver tumour, Biopsy needle guidance