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
danel@endostream.com
Trial website
Contact information
Type
Public
Primary contact
Mr Danel Mayer
ORCID ID
Contact details
12 HaÍlan St
PO Box 265
Or Akiva
3065201
Israel
+972 (0)4 842 4810
danel@endostream.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CLD219
Study information
Scientific title
Nautilus endovascular device for wide neck cerebral aneurysm embolization study
Acronym
NEW
Study hypothesis
Safety and effectiveness of the investigational device.
Ethics approval
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: cephgf.ce@gmail.com), approval number: 3.708.271, EC ID number: 23797919.1.0000.5040
Study design
Interventional single-arm study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cerebral aneurysm
Intervention
Patients will undergo a single intervention with the Nautilus Endovascular Device followed by treatment follow up at 6 months.
Intervention type
Device
Phase
Not Applicable
Drug names
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
01/01/2020
Overall trial end date
01/06/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients who present with intracranial aneurysm
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
Unstable neurological deficit
Recruitment start date
01/03/2020
Recruitment end date
01/03/2021
Locations
Countries of recruitment
Israel
Trial participating centre
Hospital Geral de Fortaleza
R. Ávila Goularte, 900 - Papicu
Fortaleza
60150-160
Brazil
Sponsor information
Organisation
EndoStream Medical Ltd
Sponsor details
12 HaÍlan St.
PO Box 265
Or Akiva
3065201
Israel
+972 (0)4 842 4810
danel@endostream.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
EndoStream Medical Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
01/06/2022
Participant level data
Not expected to be available
Basic results (scientific)
Publication list