Identification of Liver Tumours Using BIP - Biopsy System

Injeq

Status: Completed

Conditions: Liver Biopsy

Treatments: Device: BIP Biopsy System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02620228

INJ-LIVERB-01

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

BIP Biopsy System

Experimental group

Description:

Biopsy system that enables real-time bioimpedance measurement from the tip of the biopsy needle.

Treatment:

Device: BIP Biopsy System