Placental Learning Model for Neurovascular Microsurgery for the Management of Intracranial Aneurysms

Intracranial Aneurysm Clinical Trial

— NeuroVasc  

Official title:

Placental Learning Model for Neurovascular Microsurgery for the Management of Intracranial Aneurysms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117527
• Other study ID #: 7907
• Status: Recruiting
• Start date: July 16, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2023
• Source: University Hospital, Strasbourg, France
• Contact: François PROUST, MD, PhD
• Phone: 33 3 88 12 76 12
• Email: francois.proust[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Locations

Country	Name	City	State
France	Service de Neurochirurgie - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the practical training of neurosurgery students	Hands-on training will be assessed by the Brain Aneurysm Microsurgery Skills Rating Scale	1 month after training students in microsurgery for brain aneurysms