LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
Recruiting
N/A
Interventional Study
Amputation of Lower Limb
Prosthesis
Non-inferiority Trial of Prothesis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Study type
- Interventional
- Purpose
- Device Feasibility
- Participants needed
- 30 (estimated)
- Sponsor
- LIMBER Prosthetics & Orthotics Inc · Industry
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About This Trial
The LIMBER UniLeg, a 3D printed single-piece transtibial prosthetic limb, is sufficiently equivalent to traditional passive prosthetic limbs (no motors or sensors), while reducing the cost and time of manufacturing and enabling global reach through the use of digital technologies to solve the worldwide prosthetic accessibility crisis. This is a single-site, Phase I, Clinical Research Study to test…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Persons, aged 18 to 75
4. In good general health as determined by clinical site monitor
5. Weight \< 125kg
6. Are …
Contacts