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PerQseal® Device for Percutaneous Vascular Closure
Study Summary
This trial tests a device used to stop bleeding from artery punctures during interventional procedures.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I had a minor procedure on my leg with a small tool and stitches or pressure for bleeding control within the last month.I have a bleeding disorder or my blood doesn't clot properly.My femoral artery is suitable for a specific closure device after a scan.I am 19 years old or older.I do not have any ongoing infections, including skin or groin infections.My kidney function is very low or I am on dialysis.I am scheduled for another leg procedure within 30 days after the first one.Surgery is not an option for my leg's condition.I am not pregnant or breastfeeding and do not plan to become pregnant during the study.I have nerve damage in my leg.I currently have COVID-19, tested positive recently, or was exposed to someone with it in the last two weeks.I had a minor procedure on my leg with a small tool and a dissolvable device to stop bleeding within the last 3 months.My leg arteries are very twisted, as shown by a CT scan.I have had a leg amputation.I had a procedure on my leg with a large tube more than 3 months ago.I have severe leg pain when walking due to a major artery in my leg being narrowed or previously treated.I need a heart or blood vessel procedure using a catheter.
- Group 1: Subjects implanted with PerQseal Vascular Closure Device
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any openings in this medical experiment currently available?
"As evidenced by clinicaltrials.gov, the trial which was initially posted on March 1st 2023 and updated lastly on March 4th 2023 is no longer recruiting patients. However, there are currently one other studies actively searching for participants."
What central objective is this research endeavor striving to achieve?
"Vivasure Medical Limited, the sponsor of this trial, will assess primary efficacy outcomes within a 30-day period. The Primary Effectiveness Endpoint is Time to Hemostasis. Additionally, secondary endpoints are being monitored including PerQseal Technical Success Rate (number of devices achieving haemostasis without manual compression or alternative treatment), PerQseal Treatment Success Rate (devices not causing Major Access Site Complications at 30 days post deployment) and Time to Device Deployment (time from insertion to removal)."
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