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IPG Replacement Study (PREFERENCE-H)

NCT02963259 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2024-07-08

Study results available
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Summary

This post-marketing evaluation has been designed to consistently investigate the subject's preference when switching from a Medtronic® constant voltage or constant current device to a St Jude Medical Infinity™ or St Jude Medical Brio™ constant current system. As electrodes will not be re-positioned, differences in subject's preference are to be explained by the difference in shape of the delivered pulse or waveform between the two systems.

Conditions

  • Parkinson Disease

Interventions

DEVICE

SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system

Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Edward Karst · Abbott

Eligibility

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

Timeline & Regulatory

Start
2017-03-29
Primary Completion
2019-11-29
Completion
2020-01-31

Countries

  • United States
  • Germany
  • Italy

Study Locations

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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 NCT02963259 on ClinicalTrials.gov