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IceExplore TF Liner Alpha Investigation
Sponsor: Össur Iceland ehf
Summary
Single group prospective repeated measures comparing breathable liner and breathable socket to conventional enclosed silicone liner and socket system. IceExploreTF liner, the investigational device, is intended to function as part of a system that replaces a missing limb, a prosthetic interface with suction suspension technology and force transmission properties. More specifically, it is intended to reduce the skin humidity associated with the closed environment of predicate liners whilst maintaining secure suspension and user comfort. The literature indicates that the impact of sweat and heat on quality of life for trans-femoral amputees is significant and actions to improve sweat and heat issues with the prosthesis can contribute substantially to the well-being of amputees and could additionally have a positive effect on residual limb skin health.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2020-10-05
Completion Date
2021-11-30
Last Updated
2026-09-04
Healthy Volunteers
No
Conditions
Interventions
IceExplore TF breathable liner and Direct Socket drilled with holes
The IceExplore TF liners are similar in intended use, methods of operation and materials to other seal-in TF silicone liners manufactured by Össur. The main difference is that the internal structure of the predicate liner is formed entirely of airtight silicone whereas the proximal 70% (approx.) of the IceExplore TF liner consists of a breathable structure, allowing water vapor to move both transversely away from the skin and longitudinally towards the proximal edge of the prosthetic socket. The investigational device is a part of a prosthesis system targeted for users with lower extremity amputation (trans-femoral amputees), physically fit for using a prosthesis to replace the function of an amputated lower limb.