CompletedNot Applicable

CorPath® GRX Neuro Study

Australia, Austria, Canada120 participantsStarted 2020-08-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Participants With Procedural Technical Success.

Timeframe: Measured from the start of the procedure to the end of the procedure.

Number of Intra- and Peri-procedural Events.

Timeframe: Measured from the start of the procedure through 24 hours or discharge, whichever occurs first.

Trial details

NCT IDNCT04236856

SponsorCorindus Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-23

Results submitted2023-09-26

View on ClinicalTrials.gov More Intracranial Aneurysm trials