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PerQseal®+ Early Feasibility Study

NCT05163548 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-04-26

No results posted yet for this study

Summary

The objective of this Early Feasibility Study (EFS) is to evaluate the initial safety and preliminary effectiveness of the PerQseal®+ VCD in a small number of subjects when used to achieve hemostasis of common femoral arteriotomies created by 14 to 22 F sheaths (arteriotomy up to 26 F) in subjects undergoing Percutaneous Transcatheter procedures.

Conditions

  • Percutaneous Large Hole Vascular Closure

Interventions

DEVICE

PerQseal Plus Device

Percutaneous closure of femoral artery access site created by 14 to 22 F sheaths (up to 26 F arteriotomy) in patients undergoing Percutaneous Transcatheter procedures.

Sponsors & Collaborators

  • Vivasure Medical Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-08
Primary Completion
2022-07-07
Completion
2022-07-07
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 NCT05163548 on ClinicalTrials.gov