"Why am I or my child not eligible for a clinical trial?"

You may have received a decision of not being eligible for a current clinical trial and there are many possible reasons.

Below is more information about:

  1. the process of Limbitless' clinical trials
  2. potential reasons why you are not currently eligible, and
  3. what to do to ensure best chances to be eligible for new clinical trials.

Contents of the page

You can click on a question to directly navigate to its answer on the page.



Q: What is a clincial trial?

Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions. In our case, our bionic devices are in clinical trials to see if they are a helpful tool for limb-different individuals to utilize in their daily lives.



Q: Why do I or does my child need to be in a clinical trial to obtain a Limbitless bionic device?

Limbitless Solutions utilizes medical partnerships and the clinical trial system to donate bionic solutions to families in need. By having our prosthetic cleared/approved as a medical device, we are ensuring higher quality technology is being delivered to trial participants. This paves the road to having our bionic solutions distributed to a wider market so Limbitless can donate to more families across the United States, and eventually, internationally.



Q: What is the process for acceptance into a clinical trial?

Limbitless will announce a collaboration with a hospital and request that all account holders on trials.Limbitless-Solutions.org refresh their information for accuracy and completeness.

All individuals and families with an account on the trials website interested in additional information will advance to a preliminary screening in Phase I.

After Phase I is complete, the hospital partner reviews the remaining applicants and determines the best matches for the trial based on their medical criteria. The final group size varies per trial. You can view all trial postings by hospital partner and its criteria at limbitless-solutions.org/trials.

The clinical team determines if you are or your child is eligible for open trial opportunities based on the information you submitted and the hospital's criteria.



Q: What does it mean to be "eligible" for a trial?

Being eligible for a trial means:

  • You or your child match the criteria that a hospital listed for the trial. All trials and their criteria are published on limbitless-solutions.org/trials. Each hospital and each trial has different inclusion and exclusion criteria.
  • Limbitless' bionic device is compatible with your or your child's limb difference.

The hospital will determine if you meet the criteria for eligibility.



Q: What are reasons an applicant would not be eligible for a clinical trial?

Some reasons include, but are not limited to, the following:

  • The applicant or the applicant's parent or guardian resides outside of the United States
    • Currently Limbitless is only able to work with hospital partners and applicants that are in the United States. Limbitless is working to expand to international partners for international applicants in the future.
  • The applicant's age falls outside of the age requirements of the trial
    • Each hospital and trial has specified different age ranges for participants. Each trial is listed at limbitless-solutions.org/trials and includes eligible ages.
  • Limbitless' current bionic technology is not compatible with the type of limb difference the applicant has
    • Limbitless' current bionic technology is most beneficial for individuals with upper limb difference on one side of the body. Our current design is most successful for those with some limb remaining below the shoulder or that ends between the elbow and the wrist. Limbitless is working to expand technological capabilities and designs for more types of limb differences; at which point new trials will be launched for those devices.
  • The hospital has not recommended the applicant for participation in the trial
  • The submitted information for the applicant was incomplete or not updated when the first decision checkpoint was reached.


Q: What should I do after I receive a "not eligible" decision?

Keep your submitted information up-to-date

  • Limbitless strongly recommends that you return to your trials portal regularly to update your information. If your information is not up to date and new trials are announced, you may receive another "not eligible" decision for a new clinical trial due to inaccurate information. Updated information ensures the best chance for you or your child to be eligible when a new opportunity becomes available.

Check limbitless-solutions.org/trials for new clinical trials

  • Limbitless works to add new hospital partners and start new trials. Just because you have received a "not eligible" decision for a current trial does NOT mean you will not be eligible for a new trial. Limbitless' trials page is up-to-date with all of Limbitless' latest clinical trials and hospital partners.

Check your email for new clinical trials and updates

  • Limbitless will also send updates and submission information edit reminders to your listed contact email if a new clinical trial opens.

Turn on push notifications for your Limbitless mobile app

  • If you downloaded the Limbitless mobile app to submit information, Limbitless will send push notifications through your app when a new trial is announced and recruitment opens.

Check and follow our social media pages @Limbitless3d

  • Limbitless will post to all of our social media platforms (Facebook, Linkedin, Twitter, and Instagram) whenever recruitment for a new clinical trial opens.

If you have more questions regarding clinical trials, you can find additional answers in the FAQ section.