On-Premise and Remote Robotic Neurointervention

Remedy Robotics, Inc.

Status: Not yet enrolling

Conditions: Cerebrovascular Disease

Treatments: Device: Remedy Robot

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06365554

2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Intervention Group

Experimental group

Description:

Group undergoing intervention with the Remedy Robot.

Treatment:

Device: Remedy Robot