Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
MuscleMetrix, LLC
Study ID
NCT07195461
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Transtibial Amputation
  • Transtibial Amputee

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Magnetic Bead Tracking System — DEVICE
    The Magnetic Beads will be implanted in a subject during either an already required revision of an existing unilateral or bilateral transtibial amputation or during the performance of a unilateral or bilateral transtibial amputation.

Study Details

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.

Key Dates

Start date
Sep 11, 2025
Status verified
Sep 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
3 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Transtibial amputees
    Up to five subjects signing an informed consent and meeting all inclusion and exclusion criteria will be enrolled into the study to receive the Magnetic Bead Tracking System. Each subject will serve as their own control in a repeated measures ('within subjects') design. During experimentation, each subject will have prosthetic gait performance measured while using the Magnetic Bead Tracking System compared to an intrinsic robotic controller.

Primary Outcome Measure

Walking Speed [ Time Frame: One timepoint, between days 150-180. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Kendall Program Manager
[email protected]
512-538-8297
Matthew J Carty, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MA

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