N/A
Completed N=120
CorPath® GRX Neuro Study
Source: ClinicalTrials.gov NCT04236856 ↗Enrolled (actual)
120
Serious AEs
34.2%
Results posted
Mar 2025
Primary outcomePrimary: Number of Participants With Procedural Technical Success. — 110 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Procedural Technical Success. |
110 | — |
| PRIMARY Number of Intra- and Peri-procedural Events. |
4 | — |
| SECONDARY Robotically Navigate Device to the Target Aneurysm |
— | — |
| SECONDARY Robotically Deploy Therapeutic Device Into the Target Aneurysm |
— | — |
| SECONDARY Overall Procedure Time |
117.3 | — |
| SECONDARY Fluoroscopy Time |
51.9 | — |
| SECONDARY Patient Radiation Exposure |
6886135.5 | — |
| SECONDARY Contrast Fluid Volume |
185.4 | — |
| SECONDARY Adverse Events |
— | — |
| SECONDARY Number of Thromboembolic Events |
17 | — |
| SECONDARY Devices Used Robotically |
— | — |
| SECONDARY Number of Participants With Aneurysm Occlusion |
71; 5; 28; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years.
- At least one cerebral aneurysm (unruptured) with indication for endovascular treatment; dome to neck ratio >1.5 or aneurysm neck width >4.0 mm.
- The Investigator deems the procedure appropriate for both manual or robotic-assisted endovascular treatment.
- The conscious subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion Criteria
- Failure / unwillingness of the subject to provide informed consent, unless the EC has waived informed consent.
- The Investigator determines that the subject or the neurovascular anatomy is not suitable for robotic-assisted endovascular treatment.
- Women who are pregnant.
- Persons under guardianship or curatorship.
Data sourced from ClinicalTrials.gov (NCT04236856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.