Actively Recruiting
Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis
Led by MuscleMetrix, LLC · Updated on 2025-09-26
3
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The investigation is an early feasibility study in up to 5 subjects, in which the primary objective is to capture preliminary safety and effectiveness information on the Magnetic Bead Tracking system.
CONDITIONS
Official Title
Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 22 to 65 years at the time of surgery
- Existing unilateral or bilateral transtibial amputation requiring revision, or a medical condition requiring a unilateral or bilateral transtibial amputation
- If no amputation yet, must have consulted a lower extremity surgical specialist and undergone psychiatric and pain medicine evaluations
- Ability to walk at variable speeds with a prosthesis at functional level K3 or above
- Adequate soft tissue and muscle mass in the operative limb for wound healing
- Ability to voluntarily activate muscles where magnetic beads will be placed
- Likely to tolerate prosthetic socket pressure during walking
- No physical limitations, addictive diseases, or medical conditions that would prevent participation
- Willingness, ability, and commitment to attend all study visits
- Ability and willingness to provide informed consent
You will not qualify if you...
- Active skin disease on the limb to be treated
- Severe other health issues, atypical skeletal anatomy, or poor physical or mental health as judged by the investigator
- Active infection, dormant bacteria, metabolic bone disease, or metastatic lesions in the residual tibia
- Weight over 285 lbs with prosthesis at screening
- Incomplete skeletal growth (open epiphyseal zones on X-ray)
- Advanced muscle wasting or poor soft tissue coverage in the operative limb
- Severe peripheral vascular disease, diabetes, skin diseases, neuropathy, severe phantom pain, or osteoporosis preventing participation
- History of systemic corticosteroids, immune-suppressive therapy, or chemotherapy within 6 months before surgery
- Known need for future MRIs
- Participation in conflicting clinical studies
- Active smokers (must be abstinent for 6 weeks pre-surgery if willing to quit)
- Pregnant, lactating, or planning pregnancy during first 12 months post-surgery
- Allergy to any device component
- Illness, disability, or living situation preventing attendance at required study visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
D
Deborah Grayeski, JD
CONTACT
K
Kendall Program Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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