Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT04236856
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years.
2. At least one cerebral aneurysm (unruptured) with indication for endovascular treatment; dome to neck ratio \>1.5 or aneurysm neck width \>4.0 mm.
3. The Investigator deems the procedure appropriate for both manual or robotic-assisted endovascular treatment.
4. The conscious subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion Criteria:
1. Failure / unwillingness of the subject to provide informed consent, unless the EC has waived informed consent.
2. The Investigator determines that the subject or the neurovascular anatomy is not suitable for robotic-assisted endovascular treatment.
3. Women who are pregnant.
4. Persons under guardianship or curatorship.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04236856
Study Brief:
Protocol Section:
NCT04236856