On-Premise and Remote Robotic Neurointervention

Cerebrovascular Disease Clinical Trial

Official title:

Safety and Feasibility of On-Premise and Remote Robotic Neurointervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06365554
• Other study ID #: 2
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: Remedy Robotics, Inc.
• Contact: David Bell, MD
• Phone: 650-441-5019
• Email: david[@]remedyrobotics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: June 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Disease
• Cerebrovascular Disorders

Intervention

Device:
• Remedy 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Remedy Robotics, Inc.	Unity Health Toronto

Outcome

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