Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 12, 2020

Primary Completion Date

August 25, 2021

Study Completion Date

September 6, 2021

Conditions
Lower Limb Amputation
Interventions
DEVICE

Active vacuum test prosthesis

The adaptive vacuum prosthesis is sold as a commercial device by the company Willow Wood with suggested U.S. L-Code L5781. The device is designated as a Class 1 Medical Device and 510(K) Exempt. This category is part of a low or moderate risk to patient safety and health. The Prosthetic socket system uses an active vacuum pump to push air out of the socket. The level of vacuum is controlled by hardware that automatically detects the socket fit based on in-socket motion and adjusts vacuum as needed to eliminate this motion.

Trial Locations (1)

46202

IU Health Methodist Hospital, Indianapolis

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Indiana University

OTHER

NCT03927404 - Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health | Biotech Hunter | Biotech Hunter