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.
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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.
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Updated 19 October 2023.
EVIDENCE - Completed
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In vitro tests show the valve is watertight of extreme high pressure (80 mmHg), showing valve functionality.
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Flow modeling study showing air bubbles cannot block the hydrophobic duct wall.
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In vivo rabbit tests (28-day study) show the implants are very well tolerated (ISO 10993).
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In vitro tests with human fallopian tube organoids show biocompatibility with materials device is made of.
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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:
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No signs of toxicity
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No effect on cell mortality
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Limited to no signs of fibrosis
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Mild to no host reaction
“For something many people consider to be impossible your first results are very encouraging" (Nils Warfving – Anapath Histology).
EVIDENCE - Ongoing & planned
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In vitro Animal gametes (sperm, ova and embryo) test to proof material biocompatibility - 2023.
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In vitro Animal oviduct on a chip to test for epithelium in- and overgrowth on the device material - 2023.
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In vivo Animal tests (sheep) stent ingrowth and removal tests - 2024.
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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:
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First in women placement and removal
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Pilot Feasibility Trial, demonstrating safety and performance to obtain CE-mark for sterilization indication
Start 2025
FDA Trials for sterilization indication
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Large numbers, randomized against SoC
Start 2026
Feasibility Trials for Contraception Indication - CE Mark
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Pregnancy, procedure and wearing safety
Start 2026