Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool

NCT03794661 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-03-31

Study results available
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Summary

The objective of this clinical investigation is to characterize the clinical performance of Abbott's Clinician Programmer Electrode Screening Mode tool (InformityTM tool) in programming InfinityTM deep brain stimulation (DBS) systems for patients with Parkinson's disease (PD) or essential tremor (ET).

Conditions

Interventions

DEVICE

Clinician programmer electrode screening mode tool

Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Bradley White · Abbott

  • Binith Cheeran · Abbott Medical Devices Neuromodulation

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-06-26
Primary Completion
2020-12-16
Completion
2020-12-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT03794661 on ClinicalTrials.gov