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

NCT05040165 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-09-10

No results posted yet for this study

Summary

Durability evaluation of a new material blend in the Iceform liner and Iceform sleeve.

Conditions

  • Prosthesis Failure

Interventions

DEVICE

Iceform liner and sleeve

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.

Sponsors & Collaborators

  • Össur Iceland ehf

    lead INDUSTRY

Principal Investigators

  • Justin L Pratt, CP · Össur

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-08
Primary Completion
2020-08-30
Completion
2020-08-30
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 NCT05040165 on ClinicalTrials.gov