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NCT05925712 · ClinicalTrials.gov registry record · NA
Aerofit Post Market Investigation
A NA study, sponsored by Össur Iceland ehf.
- Completed
- Registry status
- NA
- Development phase
- 56
- Enrollment target
NCT05925712: Completed NA study, sponsored by Össur Iceland ehf.
NCT05925712 is a NA study that has completed, run by Össur Iceland ehf. The registered enrollment target is 56 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05925712, a NA study, has completed, sponsored by Össur Iceland ehf.
- COMPLETED
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
Study Summary
The goal of this clinical investigation is to evaluate the clinical benefits of a ventilating suspension interface for individuals with transfemoral amputation. The main aim of the investigation will be to evaluate the clinical user-reported benefits to skin health from using a ventilating lower limb prosthetic suspension system and compare it to a non-ventilating suspension system.
Primary Outcome
PEQ-RLH (Prosthesis Evaluation Questionnaire - Residual Limb Health) Questionnaire Mean of six 1-10 point scale items, higher score indicates better RLH
Interventions
- DEVICE AeroFit Seal-In Liner / Socket
- DEVICE Seal-In Silicone Liner
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2023-06-06 |
| Est. Completion | 2024-05-31 |
| Phase | NA |
What the finished NCT05925712 record still lists
NCT05925712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which AeroFit Seal-In Liner / Socket is the first listed.
NCT05925712 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05925712 about?
NCT05925712 is a clinical study titled "Aerofit Post Market Investigation". The goal of this clinical investigation is to evaluate the clinical benefits of a ventilating suspension interface for individuals with transfemoral amputation. The main aim of the investigation will be to evaluate the clinical user-reported benefits to skin health from using a ventilating lower lim...
What is the current status of trial NCT05925712?
This trial is currently completed. It is a NA study. The enrollment target is 56 participants. The study started on 2023-06-06. Estimated completion is 2024-05-31.
What interventions are being tested in trial NCT05925712?
The interventions under investigation include: AeroFit Seal-In Liner / Socket (DEVICE), Seal-In Silicone Liner (DEVICE).
Who is sponsoring clinical trial NCT05925712?
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 NCT05925712's enrollment target sits among peer trials
56 1262nd of 2000 higher than 737 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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