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

NCT07195461 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-09-26

No results posted yet for this study

Summary

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

  • Transtibial Amputee
  • Transtibial Amputation

Interventions

DEVICE

Magnetic Bead Tracking System

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.

Sponsors & Collaborators

  • MuscleMetrix, LLC

    lead INDUSTRY

Principal Investigators

  • Matthew J. Carty, M.D. · Brigham and Women's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-11
Primary Completion
2026-04-30
Completion
2026-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07195461 on ClinicalTrials.gov