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xDot Access Management System Early Feasibility Study

NCT07464353 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-17

No results posted yet for this study

Summary

The objective of this study is to demonstrate safety and investigate effectiveness of the xDot Access Management System (AMS) for closure of large bore femoral-arterial and femoral-venous access sites.

Conditions

  • Vascular Closure Devices

Interventions

DEVICE

xDot Access Management System (AMS)

The xDot AMS is designed to deliver the xDot Implant Unit in the anterior wall of the target vessel to close the puncture site.

Sponsors & Collaborators

  • Bright Research Partners

    collaborator INDUSTRY

  • xDot Medical, Inc

    lead INDUSTRY

Principal Investigators

  • Ben Smith, PhD · Bright Research, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-16
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07464353 on ClinicalTrials.gov