Ongoing clinical studies

Open single arm multicenter study
Multicentre German study for evaluation of NeoNavia in axillary lymph nodes. (PULSE) Percutaneous Ultrasonic-guided Biopsy Evaluation for Axillary Lymph Node Sampling Efficacy,

Purpose: Demonstration of product performance for ultrasound-guided biopsies of axillary lymph nodes in patients with breast cancer.
Primary investigator: Prof. Marc Thill; Agaplesion Markuskrankenhaus, Frankfurt
Collaborative partners: AWOgyn e.V, a working group for breast cancer surgery within the German Association for Obstetrics and Gynaecology (DGGG) Identifier: NCT03975855
Study centres:

  • Agaplesion Markuskrankenhaus Frankfurt
  • Klinikum Esslingen
  • Universitäts-Frauenklinik Tübingen
  • Klinikum Essen-Mitte
  • Klinikum Südstadt Rostock
  • Hermann-Josef-Krankenhaus Erkelenz
  • Universitätsklinikum Köln

Randomized controlled multicenter study
British randomized multicentre study for comparison between NeoNavia and conventional 14G CNB for sampling in axillary lymph nodes (XXXX).

Purpose: Demonstration of product benefits over today's standard for ultrasound-guided biopsies of axillary lymph nodes in breast cancer patients.
Primary investigator: Dr Anthony Maxwell MB, ChB, FRCSEd, FRCR; Nightingale Centre, Wythenshawe Hospital, Manchester Identifier: NCT0_TBD
Study centres:

  • Wythenshawe Hospital, Manchester University NHS Foundation Trust (MFT), Manchester
  • Addenbrooke 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

Retrospective single center study
Retrospective Swedish analysis of NeoNavia® for ultrasonic-guided biopsy of breast tumours (NEO)

Purpose: Demonstration of product performance in ultrasonic-guided breast tumour biopsies
Primary investigator: Docent Edward AzavedoKarolinska Sjukhuset, Stockholm Identifier: NCT0_TBD
Study center:

  • Karolinska Sjukhuset, Stockholm