NCT06117527 Placental Learning Model for Neurovascular Microsurgery for the Management of Intracranial Aneurysms
| NCT ID | NCT06117527 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Intracranial Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-07-16 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2020-07-16 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06117527 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intracranial Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06117527 currently recruiting?
Yes, NCT06117527 is actively recruiting participants. Contact the research team at irene.ollivier@chru-strasbourg.fr for enrollment information.
Where is the NCT06117527 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT06117527 clinical trial?
NCT06117527 is sponsored by University Hospital, Strasbourg, France. The trial plans to enroll 50 participants.