Evaluation of Safety and Efficacy of the Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression

NCT05554471 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2025-04-24

Study results available
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Summary

ReliaSeal is a clinical trial designed to evaluate safety and efficacy of use of MYNX CONTROL™ Venous Vascular Closure Device 6F-12F vs. manual compression to seal femoral access sites in patients who have undergone endovascular procedures utilizing up to 12F procedural sheaths in one or both limbs.

Conditions

  • Venous Vascular Closure

Interventions

DEVICE

MYNX CONTROL™ Venous Vascular Closure Device 6F-12F

Mynx Control Venous VCD 6F-12F is indicated for use to seal femoral venous access sites while reducing times to hemostasis and ambulation.

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER
  • Cordis Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-30
Primary Completion
2023-07-11
Completion
2023-07-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05554471 on ClinicalTrials.gov