About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

Medical device clinical trials (MDCTs) are investigations or examinations undertaken to assess the safety or the performance of a medical device in terms of its use in treatment, prevention or diagnosis of diseases in human subjects.

MDCTs are different from drug trials in that only patients with the condition which the device is designed to treat are involved. MDCTs are traditionally comprised of three different types of studies:

  • Exploratory or Feasibility Study – Exploratory studies (also knowns as feasibility studies) are conducted in the early stages of the medical device development. They are used to establish preliminary safety and effectiveness of the device and to design the next stage of the trial, the pivotal study.
  • Pivotal Study – Pivotal studies are performed to demonstrate the device safety and effectiveness in terms of its specific use within a specific patient population. The results obtained from a pivotal study are used to gain regulatory approval to market the device.
  • Post-market Study – Post-market study could run either as a condition of approval to meet a business objective, or to better understand long-term effectiveness of the device and potential adverse events associated with the use of the device.

Being familiar with the specifications and format of drug and MDCTs can help all participants (including medical professionals, clinical staff and patients) ensure the trials run as smoothly and efficiently as possible.

More Questions? We're here to help!