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NCT04388488 · ClinicalTrials.gov registry record · NA
Connect TF - An Investigation of Function and Usability of a New Adaptable Socket System
A NA study, sponsored by Össur Iceland ehf.
- Completed
- Registry status
- NA
- Development phase
- 9
- Enrollment target
NCT04388488: Completed NA study, sponsored by Össur Iceland ehf.
NCT04388488 is a NA study that has completed, run by Össur Iceland ehf. The registered enrollment target is 9 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04388488, a NA study, has completed, sponsored by Össur Iceland ehf.
- COMPLETED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
Study Summary
The primary objective of this investigation is to evaluate how the CONNECT TF compares to traditional handmade sockets, specifically that it provides reliable suspension and improved usability and comfort for the amputee, and that it enables single clinical visit for fitting.
Primary Outcome
CLASS is a self-report measure of prosthetic socket satisfaction for lower limb amputees, designed to provide an effective means of communication for the patient to describe with clarity, the quality of their socket fit during common activities. CLASS evaluates static and dynamic features of socket stability, suspension, comfort and appearance and has been reported to be a reliable, quick and easy report measure.
Interventions
- DEVICE CONNECT TF adaptable socket system
- DEVICE Any conventional handmade socket
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-08-03 |
| Est. Completion | 2022-01-25 |
| Phase | NA |
What the finished NCT04388488 record still lists
NCT04388488 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which CONNECT TF adaptable socket system is the first listed.
NCT04388488 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04388488 about?
NCT04388488 is a clinical study titled "Connect TF - An Investigation of Function and Usability of a New Adaptable Socket System". The primary objective of this investigation is to evaluate how the CONNECT TF compares to traditional handmade sockets, specifically that it provides reliable suspension and improved usability and comfort for the amputee, and that it enables single clinical visit for fitting.
What is the current status of trial NCT04388488?
This trial is currently completed. It is a NA study. The enrollment target is 9 participants. The study started on 2020-08-03. Estimated completion is 2022-01-25.
What interventions are being tested in trial NCT04388488?
The interventions under investigation include: CONNECT TF adaptable socket system (DEVICE), Any conventional handmade socket (DEVICE).
Who is sponsoring clinical trial NCT04388488?
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 NCT04388488's enrollment target sits among peer trials
9 1975th of 2000 higher than 25 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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