To develop safe and performing instruments or devices for intra-uterine endoscopic fetoplacental interventions, including new small diameter optics, amniotic distension and coagulation devices. fibre-optical monitoring devices and techniques for chronic catheterisation and aminiotic sealing. tested in animal experiments and where applicable validate it in man.
To set up a register of operative fetoscopies which will allow to bridge the gap between actual investigational procedures and routine established clinical practice.
The unborn foetus has become a patient to whom diagnosis and therapy is offered prior to birth. Occasionally invasive procedures are needed for foetal diagnosis and therapy For diagnostic purposes, only seldom fetoscopy, being the insertion of an endoscope in the amniotic cavity is needed, since ultrasound resolution has improved so much. Ultrasound today is also used to guide invasive procedures, such as needle insertion to sample fetoplacental tissues. or to inject substances e g intra-uterine transfusion In some rare conditions the foetus needs to be operated on during its intra-uterine life. Foetal surgery actually requires maternal laparotomy hysterotomy, and temporary exposure of the foetus. Such a procedure is unfortunately associated with poor foetal outcome while being very invasive to the mother.
More recently fetoscopy has been revived to operate on the foetus and placenta, which opened new perspectives for foetal medicine Minimal invasive endoscopic procedures do not require exteriorisation of the foetus, who can so be maintained in its natural environment. This is associated with less foetal and maternal morbidity Some clinical procedures, such as laser coagulation of feto-placental vessels, or cord ligation, have gained acceptance and saved some foetuses that would otherwise not have survived However further implementation and extension of fetoscopic techniques is hampered by technical limitations, a firm scientific basis and scattered individual experience.
This unique European joint venture of manufacturers of endoscopic equipment, and tertiary referral centres in foetal medicine propose a project to bridge the gap between actual experimental procedures and routine established clinical practice. Necessary technical developments meeting the safety- and performance requirements for intra-uterine endoscopic fetoplacental interventions will be developed by manufacturers and clinicians. This will involve new small diameter and high resolution autoclavable optics, and a safe device for intra-amniotic distension Fibre-optical monitoring devices and chronic catheterisation techniques will be designed, as well as novel techniques for hemostasis. Techniques for sealing the amniotic membranes access will be investigated. The performance of these technical achievements will first be the subject of animal experiments, and subsequently will be validated in the clinical situation.
This project will offer the technical and scientific basis to implement fetoscopy as a widely applicable and accepted clinical tool. Technical achievements will however have applications far beyond the field of foetal medicine: multiple spin-off applications of the developed instruments are suggested, such as microcatheterisation techniques, optical monitoring devices, mini-endoscopes and distension devices for hysteroscopy and laparoscopy. Instrumental developments will be a strong impetus for the European medical industry, and clinical achievements will be considered as European landmarks.
Funding SchemeCSC - Cost-sharing contracts
171 76 Stockholm