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Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP

NCT04157608 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-10-10

No results posted yet for this study

Summary

The purpose of this research is to validate the e-MIP design and function by testing the ability of e-MIP to harvest energy and return a sufficient amount of energy to assist the user during gait. The investigators will also evaluate whether prosthetic users are able to wear and use the e-MIP device long-term.

Conditions

  • Transtibial Amputation
  • Artificial Limbs

Interventions

DEVICE

Habitual Prosthesis

Habitual baseline prosthesis prescribed by participant's clinician.

DEVICE

Energy-Harvesting Mesofluidic Impulse Prosthesis

e-MIP is an experimental lower limb ankle-foot prosthesis.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Orthocare Innovations, LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-02
Primary Completion
2022-07-10
Completion
2022-07-10
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 NCT04157608 on ClinicalTrials.gov