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Identification of Liver Tumours Using BIP - Biopsy System

This study is currently recruiting participants.
Verified June 2017 by Injeq Ltd
Sponsor:
ClinicalTrials.gov Identifier:
NCT02620228
First Posted: December 2, 2015
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Injeq Ltd
  Purpose
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.

Condition Intervention
Liver Biopsy Device: BIP Biopsy System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: INJ-LIVERB-01 Identification of Liver Tumours Using BIP - Biopsy System

Resource links provided by NLM:


Further study details as provided by Injeq Ltd:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: May 2016
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620228


Contacts
Contact: Kirsti Numminen, PhD MD +358 50 427 1314 kirsti.numminen@hus.fi

Locations
Finland
Helsinki University Hospital, Department of Radiology Recruiting
Helsinki, HUS, Finland, FI-00029
Contact: Kirsti Numminen, PhD MD       kirsti.numminen@hus.fi   
Sponsors and Collaborators
Injeq Ltd
Investigators
Principal Investigator: Kirsti Numminen, PhD MD Helsinki University Hospital, Department of Radiology
  More Information

Responsible Party: Injeq Ltd
ClinicalTrials.gov Identifier: NCT02620228     History of Changes
Other Study ID Numbers: INJ-LIVERB-01
First Submitted: November 20, 2015
First Posted: December 2, 2015
Last Update Posted: June 6, 2017
Last Verified: June 2017

Keywords provided by Injeq Ltd:
Bioimpedance
Biopsy
Liver tumour
Biopsy needle guidance

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases