Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05040165 |
Other study ID # |
CIP2019052102 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 8, 2019 |
Est. completion date |
August 30, 2020 |
Study information
Verified date |
September 2021 |
Source |
Össur Ehf |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Durability evaluation of a new material blend in the Iceform liner and Iceform sleeve.
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.