On-Premise and Remote Robotic Neurointervention

NCT ID: NCT06365554

Last Updated: 2024-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-06-01

Brief Summary

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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

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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.

Conditions

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Cerebrovascular Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Intervention Group

Group undergoing intervention with the Remedy Robot.

Group Type EXPERIMENTAL

Remedy Robot

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role collaborator

Remedy Robotics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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David Bell, MD

Role: CONTACT

650-441-5019

Other Identifiers

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2

Identifier Type: -

Identifier Source: org_study_id

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