On-Premise and Remote Robotic Neurointervention

NCT06365554 | Not Yet Recruiting DMC

• 1 other identifier: 2
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebrovascular Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Intervention Group

EXPERIMENTAL

Group undergoing intervention with the Remedy Robot.

Device: Remedy Robot

Interventions

Remedy Robot DEVICE

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Remedy Robotics, Inc.: lead
• Unity Health Toronto: collaborator

MeSH Terms

Conditions

Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

David Bell, MD

CONTACT

650-441-5019; david@remedyrobotics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 15, 2024
• Study Start: June 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share