Product Surveillance Registry

  • STATUS
    Recruiting
  • End date
    Jan 30, 2030
  • participants needed
    100000
  • sponsor
    Medtronic
Updated on 30 September 2020

Summary

The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

Details
Clinical Study IdentifierNCT01524276
SponsorMedtronic
Last Modified on30 September 2020

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Eligibility

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Inclusion Criteria

Gender: Male or Female
Do you have any of these conditions: Aortic, Peripheral Vascular and Venous Disorders or Respiratory Therapy or URINARY TRACT DISORDER or Aneurysm or Cardiac Rhythm Disorders or Sacral Ne...?
Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
Patient has or is intended to receive or be treated with an eligible Medtronic product
Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment

Exclusion Criteria

Patient who is, or will be, inaccessible for follow-up
Patient with exclusion criteria required by local law
Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
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How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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