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

NCT06117527 | Recruiting

• 1 other identifier: 7907
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Aneurysm

Keywords

Intracranial aneurysm; Placental learning model; Neurovascular microsurgery; Aneurysm

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Neurochirurgie - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Irène OLLIVIER, MD

CONTACT

33 3 88 12 76 24; irene.ollivier@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 7, 2023
• Study Start: July 16, 2020
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

FR (1)