COMPULSE Vers.1.0_13September2019

• Research type

  Research Study

• Full title

  Comparison trial of open-tip pulsed needle biopsy and conventional core biopsy in axillary lymph nodes (COMPULSE)

• IRAS ID

  270952

• Contact name

  Kai-Uwe Schässburger

• Contact email

  kai-uwe.schassburger@neodynamics.se

• Sponsor organisation

  NeoDynamics AB

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  This is a Sponsor-initiated multicentre randomised study in the UK (England). The aim of the study is to compare performance and safety of a newly developed 14-gauge open-tip pulsed biopsy needle (OT-PNB) with a conventional 14-gauge core biopsy needle (CNB)for sampling of radiologically indeterminate or suspicious axillary lymph nodes in women with radiologically suspected breast cancer. At the time of radiological breast cancer diagnosis women with ultrasonically abnormal lymph nodes undergo axillary sampling using the NeoNavia biopsy system or a common CNB device. This is in accordance with clinical routine and current clinical guidelines. The NeoNavia biopsy system is approved for use in the axillary lymph nodes.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  19/NW/0648

• Date of REC Opinion

  21 Nov 2019

• REC opinion

  Favourable Opinion