On-Premise and Remote Robotic Neurointervention

Safety and Feasibility of On-Premise and Remote Robotic Neurointervention

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06365554

Enrollment

Registered

2024-04-15

Start date

2024-06-01

Completion date

2025-06-01

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Disease

Brief summary

This study is a prospective, single arm, single-center study to evaluate the safety and feasibility of the Remedy Robot for on premise and remote robotic Neurointervention.

Detailed description

This is a prospective, single-arm, single-center study to evaluate the safety and effectiveness of the Remedy Robot for patients with a clinical indication for Neurointervention.

Interventions

DEVICERemedy Robot

A trained Neurointerventionalist will operate the Remedy Robot from a computer-based user interface in a room adjacent to the patient. An entire cerebral angiogram or cerebral embolization will be performed, excluding insertion and removal of the femoral sheath.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* The patient is ≥ 18 years of age * The Investigator deems the patient appropriate for manual and robotic-assisted Neurointervention. * The patient or their substitute decision-maker has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.

Exclusion criteria

* Patients currently pregnant or breastfeeding. * People with any of the following vascular history: * Known congenital aortopathy, connective tissue disorder or vasculopathy * Known arterial dissection of any kind * Bleeding diathesis * Use of Warfarin, IV Heparin, Clexane, Fondaparinux or any new oral anticoagulants (NOACs) or direct oral anticoagulants (DOACs) People with any of the following medical history: * Active malignancy * Known contrast allergy * Height \> 190cm

Design outcomes

Primary

Measure	Time frame	Description
Procedural safety	Measured from the start of the procedure through 24 hours or discharge	Incidence of intra- and peri-procedural events, including all cause mortality, stroke, arterial dissection, arterial perforation
Procedural Technical Success	Measured from the start of the procedure through to the completion of the procedure	Successful completion of the robotic-assisted endovascular procedure absent any unplanned conversion to manual control

Contacts

Primary ContactDavid Bell, MD

david@remedyrobotics.com650-441-5019

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026