Investigation on Failure Time Analysis of a New TPE Material in the Iceform Liner

Study Overview
=================
Brief Summary
-----------------
Durability evaluation of a new material blend in the Iceform liner and Iceform sleeve.

Detailed Description
-----------------
Potential subjects will be identified from the customer base of a relevant clinic. If a potential participant may fit the inclusion and exclusion criteria, he/she will be contacted by a Co-Investigator (CI) via telephone. During the telephone call the CI will verify if they are interested in participating in a study and will initiate the enrollment procedure. If interest is expressed at this point they will answer some screening questions and if the eligibility criteria is met the subject is offered to enroll by getting a study invite through ProofPilot, the EDS, and an appointment to come in for initial fitting will be set up. Questions relating to the duration of the study, number of clinical visits required, and the investigational device will be answered at this time. Following this the subject will log into ProofPilot online and go through the e-ICF, if signed, the subject will answer a profile questionnaire. The next step will be an appointment, subject comes into their clinic and gets the investigational device. In some cases, the subject will get the liner shipped to their home address. This will only be done upon subjects request due to long distance from clinic. And only for very confident prosthetic users which are used to handle a new liner by themselves. Potential risk of participating in the investigation will be explained to the subject at this point. The CIs will communicate to the study monitors the number of users that have been identified that meet the inclusion/exclusion criteria and are willing to participate. During the clinical visit the subjects will only be fitted to the Iceform investigational liner. Profile and relevant contact information will already have been collected via the EDS. Subjects will then receive a prompt monthly, either via email, SMS or smartphone notification, to fill in the EDS questionnaire, and perform any tasks as applicable. If a subject reports a failure he/she will be instructed to stop using the liner, the remaining gift cards will be delivered and their participation ends. Otherwise, participation will end at 6 months. The subject gets to keep the investigational device at the end of the study, therefore there is no need for an additional visit. Subjects that report a failure of the TPE material may be contacted by the Coordinating Investigator or CI if the root cause of the failure cannot be confidently determined from the data collected with the EDS system.

Official Title
-----------------
Investigation on Failure Time Analysis of a New TPE Material in the Iceform Liner

Conditions
-----------------
Prosthesis Failure

Intervention / Treatment
-----------------
* Device: Iceform liner and sleeve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Trans-tibial amputee Uses an Iceform or Willow Wood Alpha Classic (Uniform profile) liner Willing and able to participate in the study and follow the protocol Confident prosthetic users for more than 3 months Older than 18 years Exclusion Criteria: Participating in another research study Participants of another research study during previous 2 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Failure time analysis<br>The primary objective is to evaluate the durability of the investigational device over its intended use lifetime (i.e. warranty period), specifically relating to any defect in the TPE material. Additionally, to gather information on the rate of side-effects, i.e. skin rashes, sores, etc. Secondary objectives relate to gather information on how amputees use the liner, specifically: Intensity of use (days/week and hours/day) Alternation; i.e. switching every other day between liners Use of personal hygiene or cosmetic products The following performance and safety aspects are to be verified: • The ICEFORM line of devices are durable over their intended use lifetime. | Device: Iceform liner and sleeve<br>* Subjects will be asked to use the investigational device as their primary prosthesis for up to 6 months. TPE material durability evaluated through monthly online questionnaires.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative failure rate | TPE material durability | 3 months | 
| Cumulative failure rate | TPE material durability | 6 months |