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NCT02438475 · ClinicalTrials.gov registry record · Phase 4
The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Venous Access-Site Closure
A Phase 4 study, sponsored by Medstar Health Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 208
- Enrollment target
NCT02438475: Completed Phase 4 study, sponsored by Medstar Health Research Institute.
NCT02438475 is a Phase 4 study that has completed, run by Medstar Health Research Institute. The registered enrollment target is 208 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02438475, a Phase 4 study, has completed, sponsored by Medstar Health Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 208 participants
- Enrollment target
Study Summary
Evaluate the safety of the MynxGrip™ extravascular sealant for common femoral vein closure following both diagnostic and interventional procedures as assessed by clinical and imaging criteria.
Primary Outcome
i. Clinical: Physical exam findings consistent with venous thrombotic/thromboembolic related complication: * Redness or swelling at the venous puncture site * Increased lower extremity edema * Calf pain * New onset or worsening shortness of breath * New onset of pleuritic chest pain ii. and if clinically indicated, imaging: venous Doppler ultrasound assessment of obstructive or non-obstructive deep vein thrombosis (DVT)
Interventions
- OTHER Manual Compression
- DEVICE Mynx Vascular Closure System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2015-06 |
| Est. Completion | 2017-08 |
| Phase | Phase 4 |
What the finished NCT02438475 record still lists
NCT02438475 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Manual Compression is the first listed.
NCT02438475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02438475 about?
NCT02438475 is a clinical study titled "The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Venous Access-Site Closure". Evaluate the safety of the MynxGrip™ extravascular sealant for common femoral vein closure following both diagnostic and interventional procedures as assessed by clinical and imaging criteria.
What is the current status of trial NCT02438475?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 208 participants. The study started on 2015-06. Estimated completion is 2017-08.
What interventions are being tested in trial NCT02438475?
The interventions under investigation include: Manual Compression (OTHER), Mynx Vascular Closure System (DEVICE).
Who is sponsoring clinical trial NCT02438475?
This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02438475's enrollment target sits among peer trials
208 399th of 2000 higher than 1,600 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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