NCT04236856

CorPath® GRX Neuro Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Corindus Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Intracranial Aneurysm
• Subarachnoid Hemorrhage
• Headache

Interventions

Type	Name	Description
DEVICE	Robotic Endovascular Procedure	After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.

Timeline

• Start date: 2020-08-21
• Primary completion: 2022-04-23
• Completion: 2022-10-12
• First posted: 2020-01-22
• Last updated: 2025-03-06
• Results posted: 2025-03-06

Locations

10 sites across 6 countries: Australia, Austria, Canada, France, Spain, Switzerland