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NCT01996982 · ClinicalTrials.gov registry record · NA
Study of a New Clinical Device for Reducing Body Core Temperature
A NA study, sponsored by Seton Healthcare Family.
- Terminated
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT01996982: Clinical Trial NA study, sponsored by Seton Healthcare Family.
NCT01996982 is a NA study that was terminated before completion, run by Seton Healthcare Family. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01996982, a NA study, was terminated before completion, sponsored by Seton Healthcare Family.
- TERMINATED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
This is a descriptive, nonrandomized, noninvasive, single-group, single-center pilot study of a Core Cooling System (CCS) device for reducing core body temperature in ICU patients at University Medical Center Brackenridge (UMCB) and Seton Medical Center Austin (SMCA). The proposed research on human subjects will provide data that will be used to improve a specialized human heat transfer technique/device. By stimulating specialized blood vessels (arteriovenous anastomoses) AVAs in the palm of the hand, it is possible to greatly increase local blood flow and thus greatly increase the potential for effective heat transfer between the environment and body. The hypothesis of this trial is that the Core Cooling System (CCS) will prove to be a practical, safe, and effective method to raise or lower body temperature in critically ill patients.
Primary Outcome
1. Assess and capture all adverse events (if any) from application and use of the CCS device. 2. Also assess CCS device interference with participant's standard of care.
Interventions
- DEVICE CCS Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2014-03 |
| Est. Completion | 2015-07 |
| Phase | NA |
Why NCT01996982 stopped before completion
NCT01996982 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which CCS Device is the first listed.
NCT01996982 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01996982 about?
NCT01996982 is a clinical study titled "Study of a New Clinical Device for Reducing Body Core Temperature". This is a descriptive, nonrandomized, noninvasive, single-group, single-center pilot study of a Core Cooling System (CCS) device for reducing core body temperature in ICU patients at University Medical Center Brackenridge (UMCB) and Seton Medical Center Austin (SMCA). The proposed research on human ...
What is the current status of trial NCT01996982?
This trial is currently terminated. It is a NA study. The enrollment target is 7 participants. The study started on 2014-03. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01996982?
The interventions under investigation include: CCS Device (DEVICE).
Who is sponsoring clinical trial NCT01996982?
This trial is sponsored by Seton Healthcare Family, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01996982's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 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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