Clinical studies

PULSE - Open single arm multicentre study
German study for the evaluation of NeoNavia for tissue sampling in axillary lymph nodes. Percutaneous Ultrasound-guided biopsy evaluated for axillary Lymph node Sampling Efficacy (PULSE).

Purpose:Demonstration of product performance for ultrasound-guided biopsies of axillary lymph nodes in patients with breast cancer.
Principal Investigator:Prof. Marc Thill, Agaplesion Markuskrankenhaus, Frankfurt.
Collaboration partners:
AWOgyn e.V., a working group for breast cancer surgery within the German Association for Obstetrics and Gynaecology (DGGG).
ClinicalTrials.gov Identifier: NCT03975855
Study centres:
  • Agaplesion Markuskrankenhaus Frankfurt
  • Klinikum Esslingen
  • Universitäts-Frauenklinik Tübingen
  • Klinikum Essen-Mitte
  • Klinikum Südstadt Rostock
  • Hermann-Josef-Krankenhaus Erkelenz
  • Universitätsklinikum Köln

COMPULSE - Randomized controlled multicentre study
British study on comparison between NeoNavia and conventional 14G CNB for tissue sampling in axillary lymph nodes (COMPULSE).

Purpose:Demonstration of product benefits over today's standard for ultrasound-guided biopsies of axillary lymph nodes in breast cancer patients.
Principal Investigator:Dr Sarah Vinnicombe MRCP FRCR, Lead Breast Radiologist, Thirlestaine Breast Centre, Cheltenham.
ClinicalTrials.gov Identifier: NCT04500262
Study centres:
  • Wythenshawe Hospital, Manchester University NHS Foundation Trust (MFT), Manchester
  • Addenbrookes's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge
  • St James's Hospital, Leeds Teaching Hospital NHS Trust, Leeds
  • The Royal Marsden, The Royal Marsden NHS Foundation Trust, London
  • King Edward VII’s Hospital, Barts health NHS Trust, London
  • King’s College hospital, King’s College Hospital NHS Foundation Trust, London
  • Western General hospital, Lothian NHS Trust, Edinburgh
  • Wycombe Hospital, Buckinghamshire Healthcare NHS Trust, High Wycombe
  • Cheltenham General Hospital, Gloucestershire Hospital NHS foundation trust, Cheltenham
  • University hospital North Durham, County Durham and Darlington NHS Foundation Trust, Durham
  • Royal Cornwall Hospital, Royal Cornwall Hospitals NHS Trust, Truro

NEO - Retrospective monocentre study
Swedish analysis of NeoNavia for ultrasound-guided biopsy of breast tumours (NEO).

Purpose:Demonstration of product performance in ultrasonic-guided breast tumour biopsies.
Principal Investigator:Associate Professor Edward Azavedo, Karolinska Sjukhuset, Stockholm.
Study centres:
  • Karolinska Sjukhuset, Stockholm