Plain English Summary
Background and study aims
The study aims to evaluate the safety and effectiveness of a new device to treat brain aneurysms.
Who can participate?
Patients with intracranial aneurysm
What does the study involve?
The study involves treatment with a minimally invasive device and a follow-up visit
What are the possible benefits and risks of participating?
Potential benefits include aneurysm healing. Like in any surgical intervention, there are possible procedure-related risks. A complete list is presented to subjects before enrollment.
Where is the study run from?
The General Hospital of Fortaleza (Brazil)
When is the study starting and how long is it expected to run for?
January 2020 to June 2021
Who is funding the study?
EndoStream Medical Ltd
Who is the main contact?
Danel Mayer, CEO
Mr Danel Mayer
12 HaÍlan St
PO Box 265
+972 (0)4 842 4810
Nautilus endovascular device for wide neck cerebral aneurysm embolization study
Safety and effectiveness of the investigational device.
Approved 16/ 11/2019, Hospital Geral de Fortaleza Ethics Committee (Comitê de Ética do Hospital Geral de Fortaleza,
Rua Avila Goulart, nº 900 - Fortaleza - CE - Brazil, 60.155-290; Tel: +55 (85)3101-7078; Email: firstname.lastname@example.org), approval number: 3.708.271, EC ID number: 23797919.1.0000.5040
Interventional single-arm study
Primary study design
Secondary study design
Non randomised study
Patient information sheet
Patients will undergo a single intervention with the Nautilus Endovascular Device followed by treatment follow up at 6 months.
Nautilus Endovascular Device
Primary outcome measure
Death or stroke in treated vascular territory measured using the NIH stroke scale at intervention and at 6 months follow-up
Secondary outcome measures
Rate of stable, successful aneurysm occlusion measured using the Raymond Roy Occlusion Classification at intervention and at 6 months follow-up
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Patients who present with intracranial aneurysm
Target number of participants
Participant exclusion criteria
Unstable neurological deficit
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Hospital Geral de Fortaleza
R. Ávila Goularte, 900 - Papicu
EndoStream Medical Ltd
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal. No additional documents are available at this time.
IPD sharing statement
The data will be held by the Principal Investigator of the study until the product becomes commercially available.
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)