NCT04157608

Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP

Evaluation of an Energy-Harvesting Mesofluidic Impulse Prosthesis (e-MIP) in Transtibial Prosthesis Users

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Orthocare Innovations, LLC · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-10-02
• Primary completion: 2022-07-10
• Completion: 2022-07-10
• First posted: 2019-11-08
• Last updated: 2023-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study