Identification of Liver Tumours Using BIP - Biopsy System

NCT02620228 | Completed

• 1 other identifier: INJ-LIVERB-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Keywords

Bioimpedance; Biopsy; Liver tumour; Biopsy needle guidance

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

BIP Biopsy System

EXPERIMENTAL

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

Device: BIP Biopsy System

Interventions

BIP Biopsy System 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.

BIP Biopsy System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Injeq Ltd: lead

Study Sites (1)

Helsinki University Hospital, Department of Radiology

Helsinki, HUS, FI-00029, Finland

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Kirsti Numminen, PhD MD

  Helsinki University Hospital, Department of Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: December 2, 2015
• Study Start: June 9, 2016
• Primary Completion: December 31, 2017
• Study Completion: November 1, 2018
• Last Updated: November 21, 2018

Record last verified: 2018-11

Locations

FI (1)