Identification of Liver Tumours Using BIP - Biopsy System

Liver Biopsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620228
• Other study ID #: INJ-LIVERB-01
• Status: Completed
• Phase: N/A
• Start date: June 9, 2016
• Est. completion date: November 2018

Study information

• Verified date: November 2018
• Source: Injeq Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Biopsy
• Liver Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Finland	Helsinki University Hospital, Department of Radiology	Helsinki	HUS

Sponsors (1)

Lead Sponsor	Collaborator
Injeq Ltd

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)