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NCT05247541 · ClinicalTrials.gov registry record · Phase 2
Diagnosing Compartment Syndrome With SHAPE vs Elastography
A Phase 2 study of Chronic Exertional Compartment Syndrome, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05247541 is a Phase 2 study of Chronic Exertional Compartment Syndrome that has completed, run by Thomas Jefferson University. The registered enrollment target is 15 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05247541, a Phase 2 study of Chronic Exertional Compartment Syndrome, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Chronic exertional compartment syndrome (CECS) is an innocuous condition seen primarily in 10-60% of young active people with exercise induced leg pain. With an average delay in diagnosis of 2 years, early identification is crucial as delays have led to poor surgical outcomes after fasciotomy. Diagnosis is currently made by compartment pressure (CP) testing, which is invasive, painful and demonstrates variable accuracy. There is no literature on the role of shear wave elastography (SWE) and/or subharmonic assisted pressure estimation (SHAPE) with microbubbles in diagnosing CECS. Ultrasound contrast agents are FDA-approved and are extremely safe. In this single-blinded prospective pilot study, the accuracy of SHAPE and SWE will be evaluated and compared to the current gold standard of compartment testing in patients with suspected CECS. Muscle stiffness and record a quantitative assessment of enhancement and hydrostatic pressures will be documented and correlated with compartment testing results based on a reference standard modified Pedowitz criteria for CECS
Conditions Studied
Interventions
- DRUG Definity
Study Locations (1)
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2023-12-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05247541
The ClinicalTrials.gov registry entry for NCT05247541 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Exertional Compartment Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Definity is the first listed.
NCT05247541 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05247541 about?
NCT05247541 is a clinical study titled "Diagnosing Compartment Syndrome With SHAPE vs Elastography". Chronic exertional compartment syndrome (CECS) is an innocuous condition seen primarily in 10-60% of young active people with exercise induced leg pain. With an average delay in diagnosis of 2 years, early identification is crucial as delays have led to poor surgical outcomes after fasciotomy. Diagn...
What is the current status of trial NCT05247541?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2020-07-01. Estimated completion is 2023-12-01.
What conditions does trial NCT05247541 study?
This clinical trial studies the following conditions: Chronic Exertional Compartment Syndrome.
What interventions are being tested in trial NCT05247541?
The interventions under investigation include: Definity (DRUG).
Who is sponsoring clinical trial NCT05247541?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05247541 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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