Study of a new medical device to treat brain aneurysms
| ISRCTN | ISRCTN96627183 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96627183 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | CLD219 |
| Sponsor | EndoStream Medical Ltd |
| Funder | EndoStream Medical Ltd |
- Submission date
- 14/01/2020
- Registration date
- 16/01/2020
- Last edited
- 04/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
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 December 2025
Who is funding the study?
EndoStream Medical Ltd
Who is the main contact?
Danel Mayer, CEO
danel@endostream.com
Contact information
Public
12 HaÍlan St
PO Box 265
Or Akiva
3065201
Israel
| Phone | +972 (0)4 842 4810 |
|---|---|
| danel@endostream.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional single-arm study |
| Secondary study design | Non randomised study |
| Scientific title | Nautilus endovascular device for wide neck cerebral aneurysm embolization study |
| Study acronym | NEW |
| Study objectives | Safety and effectiveness of the investigational device. |
| Ethics approval(s) |
Approved 16/11/2019, Hospital Geral de Fortaleza/SUS (Government Unified Health System) (Rua Avila Goulart, nº 900, Fortaleza, 60.155-290, Brazil; +55 (85) 3101-7078; cephgf.ce@gmail.com), ref: 3.708.271 |
| Ethics approval additional information | 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 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Nautilus Endovascular Device |
| Primary outcome measure(s) |
Death or stroke in treated vascular territory measured using the NIH stroke scale at intervention and at 6 months follow-up |
| Key secondary outcome measure(s) |
Rate of stable, successful aneurysm occlusion measured using the Raymond Roy Occlusion Classification at intervention and at 6 months follow-up |
| Completion date | 01/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | Patients who present with intracranial aneurysm |
| Key exclusion criteria | Unstable neurological deficit |
| Date of first enrolment | 01/09/2022 |
| Date of final enrolment | 30/06/2025 |
Locations
Countries of recruitment
- Brazil
- Israel
Study participating centre
Fortaleza
60150-160
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The data will be held by the Principal Investigator of the study until the product becomes commercially available. |
Editorial Notes
04/06/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 30/06/2024 to 30/06/2025.
2. The overall study end date was changed from 01/12/2024 to 01/12/2025.
3. The intention to publish date was changed from 01/12/2025 to 01/12/2026.
04/01/2024: The recruitment end date was changed from 09/01/2024 to 30/06/2024.
07/12/2023: The recruitment end date was changed from 01/09/2024 to 09/01/2024.
06/11/2023: Internal review.
08/06/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/03/2020 to 01/09/2022.
2. The recruitment end date was changed from 01/03/2022 to 01/09/2024.
3. The overall trial end date was changed from 01/06/2022 to 01/12/2024.
4. The intention to publish date was changed from 01/06/2023 to 01/12/2025.
03/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/03/2021 to 01/03/2022.
2. The overall end date was changed from 01/06/2021 to 01/06/2022.
3. The intention to publish date was changed from 01/06/2022 to 01/06/2023.
4. The plain English summary was updated to reflect these changes.
16/01/2020: Trial's existence confirmed by Hospital Geral de Fortaleza Ethics Committee.
