New registry tracks vein Sealer's Real-World performance
NCT ID NCT07246902
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 3 times
Summary
This study is a registry that collects information on how well a device called MYNX CONTROL VENOUS works in everyday medical practice. It seals the small hole in a leg vein after certain heart or blood vessel procedures. About 300 people will take part, and researchers will track if they can go home the same day without problems like bleeding or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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339 people
The number who actually took part.
- Started
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Nov 2025
- Finished
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Aug 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study includes patients who undergo catheter-based procedures utilizing 6F to 12F inner diameter procedural sheaths, with single or multiple venous access sites in one or both limbs, and have their venous access site(s) closed with MYNX CONTROL™ VENOUS VCD 6F-12F per IFU.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. Able and willing to provide informed consent and to complete a follow-up visit at 14 ± 7 days post-procedure. 2. Individuals undergoing catheter-based procedures utilizing 6F to 12F inner diameter procedural sheaths, with single or multiple venous access sites in one or both limbs. 3. Individuals who are candidates to have their venous access site(s) closed with MYNX CONTROL™ VENOUS VCD 6F-12F per IFU. 4. At the time of enrollment, the Investigator deems the subject a candidate for same-day discharge (SDD) per standard of care (no procedure related events/complications e.g., no new pericardial effusion, post-procedure diuresis not needed, etc.). Exclusion Criteria 1. Presence of bruit, palpable aneurysm, significant candida or groin infection. 2. Prior to closure, presence of hematoma in the accessed limb. 3. Currently involved in any other clinical trial that may interfere with the outcomes of this study as determined by the Investigator. 4. Planned use of other closure devices or techniques other than MYNX CONTROL™ VENOUS VCD 6F-12F. 5. Life expectancy \<12 months.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AdventHealth Orlando
Orlando, Florida, 32803, United States
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Baptist Health Lexington
Lexington, Kentucky, 40503, United States
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Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
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Glenbrook Hospital
Glenview, Illinois, 60026, United States
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KC Heart and Rhythm Institute
Overland Park, Kansas, 66211, United States
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North Carolina Heart & Vascular Research, LLC
Raleigh, North Carolina, 27607, United States
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Overlake Medical Center
Bellevue, Washington, 98004, United States
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South Denver Cardiology
Littleton, Colorado, 80210, United States
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Stanford University School of Medicine
Palo Alto, California, 94304, United States
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