A Medical Device to Treat Brain Aneurysms

NCT ID: NCT04963933

Last Updated: 2022-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-17

Study Completion Date

2022-04-30

Brief Summary

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An aneurysm is a bulge in a blood vessel caused by a weakness in the blood vessel wall, usually where it branches. As blood passes through the weakened blood vessel, the blood pressure causes a small area to bulge outwards like a balloon. Most brain aneurysms only cause noticeable symptoms if they burst (rupture). This leads to an extremely serious condition known as a subarachnoid hemorrhage, where bleeding caused by the ruptured aneurysm can cause extensive brain damage and symptoms.

The study aims to evaluate the safety and effectiveness of a medical device to treat brain aneurysms.

Detailed Description

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Patients will be treated with the Nautilus, then will be followed up for up to 6 months.

Conditions

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Cerebral Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients treated with the device

Patients treated with the Nautilus will be followed up

Group Type EXPERIMENTAL

Nautilus endovascular device

Intervention Type DEVICE

Patients will be treated with the Nautilus Endovascular device followed by treatment follow up for up to 6 months

Interventions

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Nautilus endovascular device

Patients will be treated with the Nautilus Endovascular device followed by treatment follow up for up to 6 months

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\* Patients who present with intracranial aneurysm

Exclusion Criteria

\* Unstable neurological deficit
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EndoStream Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St. Ivan Rilski University hospital

Sofia, , Bulgaria

Site Status

Paula Stradina university hospital

Riga, , Latvia

Site Status

Countries

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Bulgaria Latvia

Other Identifiers

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CLD-262

Identifier Type: -

Identifier Source: org_study_id

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