GUIDE TO UNDERSTANDING

TRIAL INFORMATION

A clinical trial, also referred to as a clinical study, research study or clinical investigation, is designed to determine if a new device or treatment will work to address a condition, treat a disease, enhance a procedure or will be of benefit to patients. In addition, clinical trials help establish the safety profile of the new device or treatment.

What are the roles of clinical trials in medical device development?

Medical device clinical trials may be run throughout development of an investigational product and after the product is on the market. The stages of clinical development for medical devices include:

Pilot

Commonly used to capture preliminary information on a medical device to adequately plan futher steps of device development
This stage often includes first in human, feasibility and other types of exploratory clinical investigations.

Pivotal

Confirmatory clinical investigations conducted to evaluate the clinical performance, effectiveness or safety of the investigational device.

Post-Market

Additional confirmatory clinical investigations to establish clinical performance or effectiveness of the medical device in a broader population of users and subjects
Also may include observational clinical investigations for better understanding of device safety, such as rare adverse events and long-term outcomes.

Adapted from ISO 14155:2020