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New Stereotactic Frame System for Neurosurgery

NCT04283812 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-08-03

No results posted yet for this study

Summary

This study is designed to demonstrate an in-house developed re-attachable stereotactic system that can markedly reduce the overall deep brain stimulation (DBS) procedure time to greatly facilitate subject access to neurosurgical restorative therapies. Subjects will consist exclusively of individuals who have been approved to undergo deep brain stimulation surgery for the treatment of a neurological disorder at Mayo Clinic - Rochester MN. This study is a quantitative comparative, between-subject study enrolling approximately 10 subjects.

Conditions

  • Parkinson Disease
  • Essential Tremor
  • Dystonia
  • Tourette Syndrome
  • Obsessive-Compulsive Disorder

Interventions

DEVICE

DBS Electrode Implantation using D1 Sterotactic System

Treatment intervention will consist of subjects undergoing Mayo Clinic standard deep brain stimulation surgery specific to their diagnosed neurological disorder consisting of implantation of stimulating electrodes using the D1 stereotactic system.

Sponsors & Collaborators

  • NaviNetics Inc.

    collaborator UNKNOWN

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Kai Miller, MD, PhD · Mayo Clinic

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04283812 on ClinicalTrials.gov