Medtronic PAN Registry (Urological and Digestive Disorders) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to keep tabs on the health status of people who have used, or who plan to use, a Medtronic® medical device to treat a urological or digestive disorder. This study is a registry, which means that it will allow us to compile information about how well these products work and how well they improve patients' quality of life.

What is the Condition Being Studied?

Urological and Digestive Disorders That Are Treated With a Medtronic® Medical Device

Who Can Participate in the Study?

Adults ages 18+ who:

  • Have a urological or digestive disorder (e.g., urinary incontinence or constipation) that is being treated, or that is planned to be treated, with a Medtronic® medical device
  • Are willing to be accessible to the study team

For more information about this study, please contact the study team at paige.green@duke.edu.

Age Group
Adults

What is Involved?

If you agree to participate in this registry, the registry staff will collect data about you and your health, together called "health information". You will be in the registry as long as you have a Medtronic® device, but you are able to withdraw at any point following your consent to join.

If you choose to join this study, it is important that you:

  • Tell your doctor about your medical history
  • Attend all visits scheduled with your doctor, and reschedule any missed appointments as soon as possible
  • Report any injuries, hospitalizations, emergency room visits, symptoms, or complaints to your doctor as soon as possible

Study Details

Full Title
Medtronic Post-Approval Network (PAN) Product Surveillance Registry
Principal Investigator
Protocol Number
IRB: PRO00043553
NCT: NCT01524276
ClinicalTrials.gov
Enrollment Status
Open for Enrollment