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Connect TF - An Investigation of Function and Usability of a New Adaptable Socket System

NCT04388488 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-10-08

No results posted yet for this study

Summary

The primary objective of this investigation is to evaluate how the CONNECT TF compares to traditional handmade sockets, specifically that it provides reliable suspension and improved usability and comfort for the amputee, and that it enables single clinical visit for fitting.

Conditions

  • Prosthesis User
  • Amputation

Interventions

DEVICE

CONNECT TF adaptable socket system

Prefabricated, adaptable socket system

DEVICE

Any conventional handmade socket

Subjects current socket

Sponsors & Collaborators

  • Indiana University

    collaborator OTHER

  • Össur Iceland ehf

    lead INDUSTRY

Principal Investigators

  • Sashwati Roy, PhD · Indiana University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2022-01-25
Completion
2022-01-25
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 NCT04388488 on ClinicalTrials.gov