Condition category
Circulatory System
Date applied
14/01/2020
Date assigned
16/01/2020
Last edited
16/01/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

endostream.com

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

Publication citations

Additional files

Editorial Notes

16/01/2020: Trial's existence confirmed by Hospital Geral de Fortaleza Ethics Committee.