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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 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. The trial reports 2 study locations across 1 state.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06648798
The ClinicalTrials.gov registry entry for NCT06648798 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LIMBER Prosthetics & Orthotics, which has 1 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
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