xDot Access Management System Early Feasibility Study for Vascular Closure
This study is testing a new device called the xDot Access Management System (AMS). This system is designed to close the puncture site in a blood vessel after a medical procedure. Researchers want to see if the xDot AMS is safe and works well for closing large holes in the femoral artery (a major artery in your leg) and femoral vein (a major vein in your leg). They will measure how quickly bleeding stops and if there are any major problems at the access site within 30 days after the procedure. You might be able to join if you are between 18 and 80 years old, can give your consent, and your doctor thinks the xDot AMS is suitable for your femoral closure. The study aims to enroll 30 participants, but its current recruitment status is unclear.
- Study design
- This is an early feasibility study that will enroll 30 participants. It is a single-arm study, meaning all participants will receive the xDot Access Management System.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 30 days after the procedure to check for major complications.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
xDot Access Management System Early Feasibility Study
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- Ben Smith, PhD · STUDY_DIRECTOR · Bright Research, Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Freedom from major complications of the target access site30 days post-procedure
- Time to hemostasis (TTH)During procedure
Defined as the elapsed time from procedural sheath removal to the first observed cessation of common femoral artery bleeding (excluding cutaneous or subcutaneous oozing at the access site).