top of page

CLINICAL EVIDENCE

CHOICE is a class III medical device as stated by the European Medical Device Regulation (2017/745) and not yet for sale in the European Union or in the United States. 

​

Currently, pre-clinical animal tests are being conducted to proof biocompatibility (under ISO10993 standards), safety and performance. In parallel, bench testing and early first in human studies with hysterectomy patients are ongoing.

​

Updated 19 October 2023.

EVIDENCE - Completed

  • In vitro tests show the valve is watertight of extreme high pressure (80 mmHg), showing valve functionality.
     

  • Flow modeling study showing air bubbles cannot block the hydrophobic duct wall.
     

  • In vivo rabbit tests (28-day study) show the implants are very well tolerated (ISO 10993).
     

  • In vitro tests with human fallopian tube organoids show biocompatibility with materials device is made of.
     

  • Ex vivo tests with freshly extirpated human, bovine and sheep uteri show perfect vision and size of the smallest endoscope in the world - part of the CHOICE placement catheter.

​28-day study in rabbits with CHOICE ONE followed by removal:

  • No signs of toxicity

  • No effect on cell mortality

  • Limited to no signs of fibrosis

  • Mild to no host reaction

“For something many people consider to be impossible your first results are very encouraging" (Nils Warfving – Anapath Histology).

Schermafbeelding 2023-10-10 om 19.19.54.png

EVIDENCE - Ongoing & planned

  • In vitro Animal gametes (sperm, ova and embryo) test to proof material biocompatibility - 2023.
     

  • In vitro Animal oviduct on a chip to test for epithelium in- and overgrowth on the device material - 2023.
     

  • In vivo Animal tests (sheep) stent ingrowth and removal tests - 2024.
     

  • In vivo Animal tests (rabbit) insemination with closed valve to show performance of closed valve (sterilization) - 2024

First in Women:

Two-step investigational Clinical Study:

  1. First in women placement and removal

  2. Pilot Feasibility Trial, demonstrating safety and performance to obtain CE-mark for sterilization indication
    Start 2025

 

FDA Trials for sterilization indication

  • Large numbers, randomized against SoC
    Start 2026
     

Feasibility Trials for Contraception Indication - CE Mark

  • Pregnancy, procedure and wearing safety
    Start 2026

bottom of page