Want To Participate in Medical Device Clinical Trials? DoNotPay Makes It a Breeze
Medical devices have a unique path during clinical trials. Unlike most other treatment options, medical devices undergo significant modifications during every phase of testing. The process of getting the device from the early stages of testing to market application can be more challenging, but the modifiable nature of devices can help.
Creating blind and randomized studies is one of the primary issues of medical device clinical trial control. Individuals may find it difficult to find clinical trials for medical devices on their own because of that. DoNotPay offers a quick and convenient way to find and participate in clinical trials for any kind of medicine or treatment option.
What Are Clinical Trials for Medical Devices?
When defining medical devices as a form of treatment, it’s important to consider how they achieve their intended purpose.
If the treatment option doesn’t have to be metabolized or doesn’t use a chemical action to reach its goal, it can be considered a medical device. Anything from a thermometer to a surgical robot will fall under this definition.
How Do Medical Device Clinical Trials Work?
According to the National Institute of Health (NIH), the definition of clinical trials is—a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions.
As medical devices are one form of medical intervention, the general rules surrounding clinical trials apply to them, with a few exceptions.
Clinical research includes testing on healthy individuals during phase I of trials. For medical devices, this phase is unnecessary. The diagnostic potential of a device can’t be tested on a healthy individual, for example.
Using placebo versions of devices is strongly discouraged, as:
- There are no practical benefits for testing a device that doesn’t work
- Testing placebo devices on patients that require diagnostics and treatment is considered unethical
How Many Classes of Medical Devices Exist?
Medical devices can be categorized into three classes, depending on their purpose and the level of risk they pose to patients:
- Class I devices—bandages, non-electric wheelchairs, handheld surgical instruments
- Class II devices—infusion pumps, computed tomography scanners, infusion pumps
- Class II devices—pacemakers and deep brain stimulators.
Class I Devices
Class I devices are considered low-risk and are often exempt from FDA review, though they must comply with quality control standards.
Class II Devices
Class II devices pose an intermediate risk to patients’ health. They don’t require clinical trial testing, but they must undergo 510(k) reviews. These reviews determine whether there is already a similar-enough treatment option available. If so, the risk might not warrant approval of the device.
Class III Devices
Class III devices are high-risk but also crucial and life-sustaining treatment options. These devices go through premarket approval before they are used on patients.
What Are the Different Medical Device Clinical Trial Phases?
Medical devices go through a different system of phases compared to their drug counterparts.
Before clinical studies begin, devices go through an Early Feasibility Study. This investigation begins before the device’s design is finalized. The early feasibility study examines clinical safety and device functionality. It involves only a few test subjects, usually fewer than ten. If bench testing can provide the needed data, this phase is skipped.
The next phase is the Pilot Study, also known as a Traditional Feasibility Study. The device should be close to its near-final or final design at this point. It is the first clinical phase, and it examines the safety and effectiveness of the device. Around ten to 30 patients are involved in the Pilot Study.
The Pivotal Study is the definitive phase for testing the safety and effectiveness of a medical device. It examines the clinical application of the device for its specific intended use. A large number of subjects are used to create statistically relevant data.
Later clinical trial phases are more heavily scrutinized by the FDA. Once the device has been approved, it moves on to post-market clinical studies.
Post-Market Medical Device Clinical Studies
After the FDA has approved a medical device, post-market studies are used to identify trends in the product’s usage. The device’s design may be modified later on, as this study provides further data about the outcomes of treatment and/or diagnostics.
Why Participate in Medical Device Trials?
There are plenty of reasons to participate in clinical trials, some of the most important ones being that:
- Clinical trials help provide crucial insights into the functionality and safety of medical devices. Without trials, there would be no way to create new treatments and diagnostic options without endangering patients with serious illnesses
- Those who participate in clinical trials will have access to the latest, cutting-edge medical procedures. The staff and researchers involved will closely monitor every aspect of a volunteer’s health, which is a level of care that they might not receive during regular check-ups
- Some trials will offer payments for healthy volunteers. While these aren’t common during medical device trials, they aren’t impossible to find, either.
DoNotPay Will Help You Find Clinical Trials for Medical Devices With Ease
Finding clinical trials is a challenging task, especially if they’re related to medical device testing. It’s like finding a needle in a haystack if the haystack were also made of needles that were difficult to find. Individuals that look up “medical device clinical trials near me” won’t have much luck, as the trials are rarer than their drug-related counterparts.
DoNotPay provides a convenient shortcut to participation in clinical trials and medical surveys of all kinds. If you want to participate in clinical research as soon as possible, you should start by accessing our app from your . From here, follow these steps to get to a trial:
- Log in to the app
- Find the Clinical Trials tab and press Get Started
- Set up the filters to narrow down your search
- Click on a study that fits the bill and press Contact
How Can I Find Medical Device Studies on My Own?
If you’re looking to find a clinical study that involves medical devices, your options are limited. It’s still possible to join studies here and there, as long as you know where to look. Here’s where you should start:
Where To Look
What To Consider When Signing Up for a Medical Device Trial
While many medical devices have predictable effects on the human body, some are a bit harder to control. Heart implants and pacemakers involve invasive surgical procedures and can lead to dangerous complications. Experimental treatment devices will always include thorough monitoring of patient health, but there’s always some level of risk involved.
As these trials seldom feature healthy patients, the benefits could outweigh the risks of participating.
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