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.

NCT07464353

xDot Access Management System Early Feasibility Study

Recruiting
NAAges 18–80InterventionalTreatment
xDot Medical, Inc
~30 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:xDot Access Management System (AMS)

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Freedom from major complications of the target access site
Measured over 30 days post-procedure
+1 more outcome measured
Vascular Closure Devices
3 sites across 3 states
Minnesota1
Oklahoma1
South Dakota1
  • Ben Smith, PhD · STUDY_DIRECTOR · Bright Research, Inc.

Opens a ready-to-send draft in your own email app — review before sending.

  • 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).