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CorPath® GRX Neuro Study | Clinical Trials | Clareo Health

COMPLETEDNA

CorPath® GRX Neuro Study

An Evaluation of Effectiveness and Safety of the CorPath® GRX System in Endovascular Embolization Procedures of Cerebral Aneurysms

NCT04236856•Corindus Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the effectiveness and safety of robotic-assisted endovascular embolization procedures compared to objective performance criteria for traditional, manual operation based on the scientific literature.

Detailed Description

This is a prospective, single-arm, international, multi- center, non-inferiority study to evaluate the effectiveness and safety of the CorPath GRX System for endovascular cerebral aneurysm embolization compared to historical controls. Subject selection requires a clinical indication for endovascular coil and/or stent-assist coiling embolization of cerebral aneurysms.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Age ≥ 18 years.
•2. At least one cerebral aneurysm (unruptured) with indication for endovascular treatment; dome to neck ratio \>1.5 or aneurysm neck width \>4.0 mm.
•3. The Investigator deems the procedure appropriate for both manual or robotic-assisted endovascular treatment.
•4. The conscious subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria

•1. Failure / unwillingness of the subject to provide informed consent, unless the EC has waived informed consent.
•2. The Investigator determines that the subject or the neurovascular anatomy is not suitable for robotic-assisted endovascular treatment.
•3. Women who are pregnant.
•4. Persons under guardianship or curatorship.

Locations (10)

Gold Coast University Hospital

Southport, Queensland, Australia

Uniklinikum Salzburg

Salzburg, Austria

Toronto Western Hospital

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Canada

Hôpital Pitié-Salpêtrière

Paris, CA, France

CHU Montpellier - Hôpital Gui de Chauliac

Montpellier, France

Hôpital de la Fondation Rothschild

Paris, France

Vall d'Hebron University Hospital

Barcelona, Spain

University Clinical Hospital of Valladolid

Valladolid, Spain

Inselspital, Universitätsspital Bern

Bern, Switzerland

Key Dates

Start Date

August 21, 2020

Primary Completion Date

April 23, 2022

Completion Date

October 12, 2022

Last Updated

March 6, 2025

Enrollment

120

ACTUAL participants

Conditions

Intracranial AneurysmSubarachnoid HemorrhageHeadache

Interventions

Robotic Endovascular Procedure

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

CorPath® GRX Neuro Study

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