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NCT02012361 · ClinicalTrials.gov registry record · Phase 1
Inspired Helium for Ischemic Protection During Knee Replacement Surgery
A Phase 1 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT02012361: Completed Phase 1 study, sponsored by University of Florida.
NCT02012361 is a Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02012361, a Phase 1 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether breathing in helium reduces indications of injury to the skeletal muscle seen in blood tests after knee replacement surgery. The ability to reduce the risk of skeletal muscle injury may help improve patient safety by providing protection to the area of the body having its blood supply interrupted during a particular surgery.
Primary Outcome
Post-operative expression of serum markers of injury to the skeletal muscle after knee arthroplasty. The primary endpoint will be detection of a decrease in the peak increase of CK detectable in the blood. A 15% decrease will be considered clinically significant.
Interventions
- PROCEDURE Muscle Biopsy
- PROCEDURE Control Group
- PROCEDURE Single-Dose Heliox Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-10 |
| Est. Completion | 2016-08 |
| Phase | Phase 1 |
What the finished NCT02012361 record still lists
NCT02012361 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 3 interventions - of which Muscle Biopsy is the first listed.
NCT02012361 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02012361 about?
NCT02012361 is a clinical study titled "Inspired Helium for Ischemic Protection During Knee Replacement Surgery". The purpose of this study is to determine whether breathing in helium reduces indications of injury to the skeletal muscle seen in blood tests after knee replacement surgery. The ability to reduce the risk of skeletal muscle injury may help improve patient safety by providing protection to the area...
What is the current status of trial NCT02012361?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2014-10. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02012361?
The interventions under investigation include: Muscle Biopsy (PROCEDURE), Control Group (PROCEDURE), Single-Dose Heliox Group (PROCEDURE).
Who is sponsoring clinical trial NCT02012361?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02012361's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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