Identification of Liver Tumours Using BIP - Biopsy System

Not Applicable

Completed

• Conditions: Liver Biopsy
• Interventions: Device: BIP Biopsy System

• Registration Number: NCT02620228
• Lead Sponsor: Injeq Ltd

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

Not available

Study Timeline

• Study First Submitted: 2015-11-20
• Study First Submitted QC: 2015-12-01
• Study First Posted: 2015-12-02
• Study Start: 2016-06-09
• Primary Completion: 2017-12-31
• Status Verified: 2018-11
• Study Completion: 2018-11
• Last Update Submitted: 2018-11-19
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BIP Biopsy System	BIP Biopsy System	Biopsy system that enables real-time bioimpedance measurement from the tip of the biopsy needle.

Primary Outcome Measures

Name	Time	Method
Difference in mean between measured bioimpedance spectra from tumorous and nontumorous tissue	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.

Trial Locations

Locations (1)

Helsinki University Hospital, Department of Radiology; 🇫🇮 Helsinki, HUS, Finland