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xDot Access Management System Pivotal Study

NCT07719244 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2026-07-22

No results posted yet for this study

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.

Conditions

  • Vascular Closure Devices

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.

Sponsors & Collaborators

  • Bright Research, Inc.

    collaborator UNKNOWN

  • xDot Medical, Inc

    lead INDUSTRY

Principal Investigators

  • Ben Smith, PhD · Bright Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Device
Yes

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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 NCT07719244 on ClinicalTrials.gov