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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 Inside Fallopian Tubes

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

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