On-Premise and Remote Robotic Neurointervention

R

Remedy Robotics, Inc.

Status

Begins enrollment this month

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)

10 participants in 1 patient group

Intervention Group
Experimental group
Description:
Group undergoing intervention with the Remedy Robot.
Treatment:
Device: Remedy Robot

Trial contacts and locations

0

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Central trial contact

David Bell, MD

Data sourced from clinicaltrials.gov

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