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Aerofit Post Market Investigation

NCT05925712 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-10-08

No results posted yet for this study

Summary

The goal of this clinical investigation is to evaluate the clinical benefits of a ventilating suspension interface for individuals with transfemoral amputation. The main aim of the investigation will be to evaluate the clinical user-reported benefits to skin health from using a ventilating lower limb prosthetic suspension system and compare it to a non-ventilating suspension system.

Conditions

  • Transfemoral Amputation
  • Amputation
  • Skin Health

Interventions

DEVICE

AeroFit Seal-In Liner / Socket

Össur AeroFit® solution is a transfemoral breathable prosthetic interface, combining the AeroFit® Seal-In liner and AeroFit® Socket.

DEVICE

Seal-In Silicone Liner

Seal-In Silicone Lineris transfemoral prosthetic interface used in combination with a prosthetic socket system.

Sponsors & Collaborators

  • Össur Iceland ehf

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-06
Primary Completion
2024-05-31
Completion
2024-05-31
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 NCT05925712 on ClinicalTrials.gov