Liver BiopsyNCT02620228
Identification of Liver Tumours Using BIP - Biopsy System
A study testing BIP Biopsy System in people with Liver Biopsy, run by Injeq Ltd at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Biopsy
- What is being tested?
- BIP Biopsy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFinland
- Study dates
- 9 Jun 2016to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Hospital, Department of Radiology
Helsinki, HUS, FI-00029
About this study
Official title: 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.
- Conditions
- Liver Biopsy
- Being tested
- BIP Biopsy System
- Keywords
- Bioimpedance, Biopsy, Liver tumour, Biopsy needle guidance
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIP Biopsy SystemDevice
BIP Biopsy system is essentially similar as traditional biopsy systems but it enables real-time bioimpedance measurement from the tip of the biopsy needle.
| Study group | Role | What they receive |
|---|---|---|
| BIP Biopsy System | Experimental | Biopsy system that enables real-time bioimpedance measurement from the tip of the biopsy needle. Receives: Device: BIP Biopsy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During liver biopsy (couple of minutes/patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study start9 Jun 2016
- Primary completion31 Dec 2017
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Injeq Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kirsti Numminen, PhD MD, Principal investigator, Helsinki University Hospital, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620228
- Sponsor's protocol ID
- INJ-LIVERB-01
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2015
- Last updated
- 21 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INJ-LIVERB-01 Identification of Liver Tumours Using BIP - Biopsy System
- ClinicalTrials.gov ID
- NCT02620228
- Acronym / sponsor ID
- INJ-LIVERB-01
- Conditions
- Liver Biopsy
- Keywords
- Bioimpedance, Biopsy, Liver tumour, Biopsy needle guidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Injeq LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIP Biopsy System | Experimental | Device: BIP Biopsy SystemBiopsy system that enables real-time bioimpedance measurement from the tip of the biopsy needle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIP Biopsy SystemBIP Biopsy system is essentially similar as traditional biopsy systems but it enables real-time bioimpedance measurement from the tip of the biopsy needle. | Device | BIP Biopsy System |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsti Numminen, PhD MD principal investigator
Helsinki University Hospital, Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIP Biopsy System in people with Liver Biopsy, run by Injeq Ltd at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean between measured bioimpedance spectra from tumorous and nontumorous tissue (time frame: During liver biopsy (couple of minutes/patient)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.