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NCT04484805 · ClinicalTrials.gov registry record · NA
Socket Cooling Effectiveness Take Home Study
A NA study, sponsored by Liberating Technologies.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT04484805: Completed NA study, sponsored by Liberating Technologies.
NCT04484805 is a NA study that has completed, run by Liberating Technologies. The registered enrollment target is 12 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
NCT04484805, a NA study, has completed, sponsored by Liberating Technologies.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm and ultimately moist environment. To address this, Liberating Technologies, Inc. (LTI) and Vivonics, Inc. have developed a thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE), that can be embedded into the prosthesis in order to cool the residual limb. A technology that can provide thermal control while retaining adequate suspension, weight and other prosthetic characteristics would benefit many prosthesis wearers.
Primary Outcome
This will be tested only during in-lab visits. An intervention of the experimental socket with the ICE cooling unit should yield at least a 2 degree Celsius decrease in temperature compared with no intervention. This will be tested in-lab with 6 thermocouples taped to the residual limb while the subject is sitting and walking on a treadmill. The reported result is the temperature difference of the residual limb from the baseline temperature (before activity) to the end of the sitting period (af
Interventions
- DEVICE ICE Condition
- DEVICE Sham Condition
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2020-11-03 |
| Phase | NA |
What the finished NCT04484805 record still lists
NCT04484805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 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 ICE Condition is the first listed.
NCT04484805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04484805 about?
NCT04484805 is a clinical study titled "Socket Cooling Effectiveness Take Home Study". The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm and ultimately moist environment. To address this, Liberating Technol...
What is the current status of trial NCT04484805?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2019-08-01. Estimated completion is 2020-11-03.
What interventions are being tested in trial NCT04484805?
The interventions under investigation include: ICE Condition (DEVICE), Sham Condition (DEVICE).
Who is sponsoring clinical trial NCT04484805?
This trial is sponsored by Liberating Technologies, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04484805's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 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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