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Active Clinical Trials

Clinical Evaluation of the Infinity DBS System (PROGRESS)

Active NCT:
02989610
Allegheny General Hospital
Allegheny General Hospital

Category:
Brain and Nerve
Contact: 

For more information, please contact Diane Cantella at 412-359-3353 or Diane.Cantella@ahn.org

Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System

Purpose: 

The purpose of this post market study is to support the chronic clinical performance of the Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG), DBS leads, extensions and related system components.

Inclusion Criteria:

  • Subject is able to provide informed consent;
  • Subjects diagnosed with Parkinson's disease (PD) and have been recommended to receive a DBS implant in the Subthalamic Nucleus (STN) or that have been implanted with an Infinity system in the STN;
  • Subject must be available for follow-up visits.

Exclusion Criteria:

  • Subject is not a surgical candidate;
  • In the Investigator's opinion the subject is unable to tolerate multiple programming sessions within a single setting;
  • Subject is unable to comply with the follow up schedule.
Eligibility Criteria: 
Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample