Clinical trial NCT06117527: Placental Learning Model for Neurovascular Microsurgery for the Management of Intracranial Aneurysms
Official title: Placental Learning Model for Neurovascular Microsurgery for the Management of Intracranial Aneurysms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Aneurysm
Keywords: Intracranial aneurysm
Placental learning model
Neurovascular microsurgery
Aneurysm
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Woman, over the age of 18, whose placenta from an adult woman, considered as surgical waste intended for incineration; with a negative infectious status verified during pregnancy follow-up

Brief summary: Training in microsurgical techniques for the management of intracranial aneurysms is carried out during the practical training of the DES in Neurosurgery and during the continuous training of neurosurgeons according to the indications of the patients of the department. Currently, the recent increase in indications for endovascular treatment compared to surgical indications has led to a decrease in surgical indications and in the experience of neurosurgeons. However, there are still surgical indications that are often complex situations that neurosurgeons must overcome with a specific simulation approach.

There are different simulation models for the treatment of intracranial aneurysms. The small animal (rodent) model has the disadvantage of being poorly suited to the reproduction of intracranial aneurysms (different extracranial vessel walls, too small intracerebral vessel caliber) and of being constraining to the establishment. The computerized stimulator model which has the advantage of being able to reproduce the anatomy of a patient but whose haptic sensitivity performance is difficult to reproduce for very fine movements, it is not very accessible because it is expensive. The placental model uses a fresh human placenta, the appearance of the vessels of which is very similar to those found intracerebrally, and dilations on their walls can be performed with a pediatric urinary catheter.


Eligibility criteria: Inclusion criteria:

* Woman over the age of 18;
* Placenta considered as surgical waste intended for incineration; with a negative infectious status verified during pregnancy follow-up
* Woman who did not express her opposition, after information, to the reuse of her placenta for educational purposes to improve the practical training of future neurosurgeons.

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* Subject under guardianship or curatorship
* Subject under safeguard of justice

Primary outcomes:
measure: Evaluation of the practical training of neurosurgery students
timeFrame: 1 month after training students in microsurgery for brain aneurysms
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Neurochirurgie - CHU de Strasbourg - France
Study officials:
References: