Identification of Liver Tumours Using BIP - Biopsy System

NCT ID: NCT02620228

Last Updated: 2018-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-09
• Study Completion Date: 2018-11-30

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.

Conditions

Liver Biopsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

BIP Biopsy System

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

Group Type: EXPERIMENTAL

BIP Biopsy System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Injeq Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirsti Numminen, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Hospital, Department of Radiology

Locations

Helsinki University Hospital, Department of Radiology

Helsinki, HUS, Finland

Countries

Finland

Other Identifiers

INJ-LIVERB-01

Identifier Type: -

Identifier Source: org_study_id