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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)
COURTNEY BISHOP
cabishop@buffalo.edu
DAWN HOLLER
dlh68@buffalo.edu
+1 716-829-6115
Want to Learn More?

Let us know how the study team can reach you. If you do not hear back within 2 business days, then reach out to the study team directly at the contact information above and someone will assist you.

Your information will be shared only with the research study team and administrative staff for recruitment and will remain confidential. Your information will be stored until study recruitment is closed. Should you no longer want this information to be provided in the aforementioned ways, please contact the study team directly.

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