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COMPLETED
NCT07858903
NA

Initial Safety and Preliminary Efficacy of the Novelrad Vascular Closure System (NVCS)

Sponsor: Novelrad Ltd.

View on ClinicalTrials.gov

Summary

This study evaluates the initial safety and preliminary efficacy of the Novelrad Vascular Closure System (NVCS), a suture-mediated vascular closure system, in achieving post-procedure hemostasis in subjects undergoing interventional catheterization procedures through the common femoral artery using large-bore procedural sheaths.

Official title: A First in Human (FIH) Clinical Study to Evaluate the Initial Safety and Preliminary Efficacy of the Suture-Mediated Novelrad Vascular Closure System

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2025-11-30

Completion Date

2026-08-18

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

DEVICE

Novelrad Vascular Closure System (NVCS)

NVCS will be used to close the common femoral artery access site while reducing time-to-hemostasis in subjects who have undergone diagnostic or interventional catheterization procedures using 8-22 French (F) Sheaths.

Locations (3)

Hadassah Medical Center

Jerusalem, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Sourasky Tel-Aviv Medical Center

Tel Aviv, Israel