NCT05749952

Digital Weight Bearing Shape Capture Socket Technology

Digital Weight Bearing Shape Capture Socket Technology to Preserve Limb Health and Improve Rehabilitation Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability \& functional outcomes than traditional sockets (non-weight bearing scanning). Additionally, the study will determine if a well-fitting socket will positively impact the overall health of amputee residual limb.

Detailed description

This study will compare the use of Symphonie Aqua Digital System, which is a new way to create a socket for prosthetics, to the current method that is generally used to create sockets. The study will look at the differences in comfort and fit between the Symphonie Aqua Digital System and the current standard of care (SOC). The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability \& functional outcomes than traditional sockets (non-weight bearing scanning). Additionally, the study will determine if a well-fitting socket will positively impact the overall health of amputee residual limb.

Conditions

• Amputation
• Prosthesis User
• Residual Limbs

Interventions

Type	Name	Description
DEVICE	Symphonie Aqua Digital System mediated sh	For socket fabrication, the shape capturing is done in full weight bearing.

Timeline

• Start date: 2023-03-06
• Primary completion: 2023-07-18
• Completion: 2023-07-18
• First posted: 2023-03-01
• Last updated: 2025-10-31
• Results posted: 2025-10-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study