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Digital Weight Bearing Shape Capture Socket Technology

NCT05749952 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-10-31

Study results available
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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.

Conditions

  • Amputation
  • Prosthesis User
  • Residual Limbs

Interventions

DEVICE

Symphonie Aqua Digital System mediated sh

For socket fabrication, the shape capturing is done in full weight bearing.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Indiana University

    lead OTHER

Principal Investigators

  • Sashwati Roy, PhD. · Indiana University

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-06
Primary Completion
2023-07-18
Completion
2023-07-18
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 NCT05749952 on ClinicalTrials.gov