Identification of Liver Tumours Using BIP - Biopsy System

November 19, 2018 updated by: Injeq Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • HUS
      • Helsinki, HUS, Finland, FI-00029
        • Helsinki University Hospital, Department of Radiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIP Biopsy System
Biopsy system that enables real-time bioimpedance measurement from the tip of the biopsy needle.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in mean between measured bioimpedance spectra from tumorous and nontumorous tissue
Time Frame: 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.
During liver biopsy (couple of minutes/patient)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Injeq Ltd

Investigators

  • Principal Investigator: Kirsti Numminen, PhD MD, Helsinki University Hospital, Department of Radiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

November 20, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (Estimate)

December 2, 2015

Study Record Updates

Last Update Posted (Actual)

November 21, 2018

Last Update Submitted That Met QC Criteria

November 19, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INJ-LIVERB-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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