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NCT06648798 · ClinicalTrials.gov registry record · NA
LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
A NA study of Prosthesis and Amputation of Lower Limb, sponsored by LIMBER Prosthetics & Orthotics.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT06648798: Recruiting NA study of Prosthesis and Amputation of Lower Limb, sponsored by LIMBER Prosthetics & Orthotics.
NCT06648798 is a NA study of Prosthesis and Amputation of Lower Limb that is actively recruiting participants, run by LIMBER Prosthetics & Orthotics. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06648798, a NA study of Prosthesis and Amputation of Lower Limb, is actively recruiting participants, sponsored by LIMBER Prosthetics & Orthotics.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
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 the effectiveness and safety of the LIMBER UniLeg. One study group of 30 participants involved for two months using a non-inferiority design in which the participant will be assessed using their normal device (1 month) and the study device (1 month).
Primary Outcome
Measure total distance for a timed six-min walk test for both the Limber UniLeg vs. existing prosthetic devices.
Conditions Studied
Interventions
- DEVICE Limber Limb
Study Locations (2)
California
- University of California San Diego - La Jolla
- Limber Prosthetics & Orthotics Inc - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-12-20 |
| Est. Completion | 2026-10-31 |
| Phase | NA |
What NCT06648798 shows while recruiting
NCT06648798 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Prosthesis appearing as the primary indexed condition, and to 1 intervention - of which Limber Limb is the first listed.
NCT06648798 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06648798 about?
NCT06648798 is a clinical study titled "LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees". 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 worldw...
What is the current status of trial NCT06648798?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2023-12-20. Estimated completion is 2026-10-31.
What conditions does trial NCT06648798 study?
This clinical trial studies the following conditions: Prosthesis, Amputation of Lower Limb, Non-inferiority Trial of Prothesis.
What interventions are being tested in trial NCT06648798?
The interventions under investigation include: Limber Limb (DEVICE).
Who is sponsoring clinical trial NCT06648798?
This trial is sponsored by LIMBER Prosthetics & Orthotics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06648798 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prosthesis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06648798's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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