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NCT00022815 · ClinicalTrials.gov registry record · Phase 1
Management of Compartment Syndrome With Ultrafiltration
A Phase 1 study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT00022815 is a Phase 1 study that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 10 participants.
The verdict
NCT00022815, a Phase 1 study, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study will test the safety of a new treatment method called tissue ultrafiltration. We will test this method in the treatment of compartment syndrome, a condition that occurs when pressure within the muscles builds to dangerous levels. In the legs and other parts of the body, a tough, stiff membrane covers groups of muscles and the nerves and blood vessels that run next to and through them. The entire unit is called a compartment. The causes of compartment syndrome include traumatic leg injuries and loss of blood supply. In tissue ultrafiltration, a doctor places hollow probes, or catheters, directly into the muscle compartment in the injured area of the lower leg. The probes remove fluid from the compartment (extra fluid can cause increased pressure). We will do an initial safety study in a group of patients who have had surgery for a broken tibia (the inner, larger bone of the lower leg) and are at high risk for developing compartment syndrome. The goals of this initial study are to show that inserting tissue ultrafiltration catheters in the muscle compartment is safe and can be done repeatedly without problems; to show that tissue ultrafiltration can be used to monitor the biochemical environment inside tissues; and to show that the catheter apparatus provides an accurate measurement of pressure in the compartment.
Interventions
- DEVICE Tissue ultrafiltration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2002-06 |
| Est. Completion | 2004-06 |
| Phase | Phase 1 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00022815
The ClinicalTrials.gov registry entry for NCT00022815 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tissue ultrafiltration is the first listed.
NCT00022815 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00022815 about?
NCT00022815 is a clinical study titled "Management of Compartment Syndrome With Ultrafiltration". This study will test the safety of a new treatment method called tissue ultrafiltration. We will test this method in the treatment of compartment syndrome, a condition that occurs when pressure within the muscles builds to dangerous levels. In the legs and other parts of the body, a tough, stiff mem...
What is the current status of trial NCT00022815?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2002-06. Estimated completion is 2004-06.
What interventions are being tested in trial NCT00022815?
The interventions under investigation include: Tissue ultrafiltration (DEVICE).
Who is sponsoring clinical trial NCT00022815?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
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