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NCT04312724 · ClinicalTrials.gov registry record · NA
An Investigation Into a New Manufacture Technique of Trans-femoral Sockets
A NA study, sponsored by Össur Iceland ehf.
- Completed
- Registry status
- NA
- Development phase
- 47
- Enrollment target
NCT04312724: Completed NA study, sponsored by Össur Iceland ehf.
NCT04312724 is a NA study that has completed, run by Össur Iceland ehf. The registered enrollment target is 47 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04312724, a NA study, has completed, sponsored by Össur Iceland ehf.
- COMPLETED
- Registry status
- NA
- Development phase
- 47 participants
- Enrollment target
Study Summary
The investigation will be of a single group prospective pre/post design with follow up at 6 weeks (6WFU) and 6 months (6MFU); comparing to outcomes at baseline (BL). Device(s) being tested: Interchangeably: Direct Socket TF; DS-TF; DS Trans-femoral. The DS-TF is a trans-femoral (TF) set-up of the currently marketed trans-tibial version. It is not marketed in the USA and has not been registered with the FDA. The comparator is the current socket the subject is using when enrolled in the study. Subjects recruited: Minimum 50 Inclusion criteria: 50Kg\< body weight \< 160Kg Cognitive ability to understand all instructions and questionnaires in the study; Patients who have undergone a transfemoral amputation \> 1 year post amputation Older than 18 years Willing and able to participate in the study and follow the protocol Circular dimension of 40-65 cm at the crotch Residual limb length at least 20 cm from ischium to distal end Currently using a prosthetic liner Locking users that can successfully be fitted with Iceross® Transfemoral Locking, OR Seal-In users that can successfully be fitted with either Iceross Seal-In® X5 TF or Iceross Transfemoral Seal-In® Exclusion criteria: 50Kg\> body weight \> 160Kg Users with cognitive impairment Patients who have undergone a transfemoral amputation \<1 year post amputation Younger than 18 years Not a prosthetic ambulator, uses only the prosthesis for cosmetic reasons Circular dimension of less than 40 cm or greater than 65 cm at the crotch Residual limb length less than 20 cm from ischium to distal end Currently not using a prosthetic liner
Primary Outcome
Patient Self report. Paper based. Evaluation of service and device.
Interventions
- DEVICE Direct Socket TF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2018-04-30 |
| Est. Completion | 2020-07-01 |
| Phase | NA |
What the finished NCT04312724 record still lists
NCT04312724 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Direct Socket TF is the first listed.
NCT04312724 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04312724 about?
NCT04312724 is a clinical study titled "An Investigation Into a New Manufacture Technique of Trans-femoral Sockets". The investigation will be of a single group prospective pre/post design with follow up at 6 weeks (6WFU) and 6 months (6MFU); comparing to outcomes at baseline (BL). Device(s) being tested: Interchangeably: Direct Socket TF; DS-TF; DS Trans-femoral. The DS-TF is a trans-femoral (TF) set-up of the ...
What is the current status of trial NCT04312724?
This trial is currently completed. It is a NA study. The enrollment target is 47 participants. The study started on 2018-04-30. Estimated completion is 2020-07-01.
What interventions are being tested in trial NCT04312724?
The interventions under investigation include: Direct Socket TF (DEVICE).
Who is sponsoring clinical trial NCT04312724?
This trial is sponsored by Össur Iceland ehf, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04312724's enrollment target sits among peer trials
47 1400th of 2000 higher than 599 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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