NCT02620228

Identification of Liver Tumours Using BIP - Biopsy System

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Injeq Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-06-09
• Primary completion: 2017-12-31
• Completion: 2018-11-01
• First posted: 2015-12-02
• Last updated: 2018-11-21

Locations

1 site across 1 country: Finland