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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06365554
Other study ID # 2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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