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NOT YET RECRUITING
NCT07719244
NA

xDot Access Management System Pivotal Study

Sponsor: xDot Medical, Inc

View on ClinicalTrials.gov

Summary

The objective of this study is to establish reasonable assurance of safety and effectiveness for the xDot Access Management System (AMS) when used as indicated for femoral-arterial and femoral-venous closure. Additionally, this study will provide preliminary evidence on the impact on health outcomes for patients undergoing interventional catheterization procedures when the xDot AMS is used for vascular closure.

Official title: xDot Access Management System Pivotal Study for Closure of Large Bore Femoral-Arterial & Venous-Access Sites

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

266

Start Date

2026-09

Completion Date

2027-09

Last Updated

2026-07-22

Healthy Volunteers

No

Interventions

DEVICE

xDot Access Management System (AMS)

The xDot AMS is designed to deliver the xDot Implant Unit around the access site on the target vessel to close the puncture site.