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New Device Study for Adults Undergoing Surgery
Protocol: STUDY00007078
Full Title
A multicentre, single-arm, pivotal study to evaluate the safety and efficacy of the Vivasure PerQseal Closure Device System when used to achieve haemostasis of common femoral arteriotomies created by 12 to 22 F sheaths in patients undergoing percutaneous catheter-based interventional procedures.
Description
The University at Buffalo (UB) Department of Medicine is looking for adults that are scheduled for a surgery that will be performed by inserting a catheter into the groin for a clinical trial. The goal of the study is to test the safety and effectiveness of a new device (the PerQseal vascular closure device system).

Participants will be enrolled in the study for about 2 years. Before the surgery, the study doctor will have you complete a physical exam, lab tests, and surveys to see if the study is right for you. Following the surgery, you will complete follow-up visits at 30 days and 180 days for additional lab tests and physical exams.
Compensation: No
Eligibility
Adults 19 years or older Are scheduled for a surgery that will insert a catheter into the groin Not currently pregnant/breastfeeding
Age Group: Adults
Principal Investigator: VIJAY IYER
ClinicalTrials.gov: Open Study
Contact(s)
DAWN HOLLER
dlh68@buffalo.edu
+1 716-829-6115
COURTNEY BISHOP
cabishop@buffalo.edu

Want to Learn More?

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