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VIOLA Post Market Surveillance Clinical Protocol

NCT05914246 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-02-06

No results posted yet for this study

Summary

The goal of this post marketing surveillance clinical trial is to learn about VIOLA as a proximal seal device in patients undergoing coronary artery grafting (CABG) surgery. The main objective is to evaluate the clinical safety and performance of the VIOLA. Participants will be treated with routine CABG with use of VIOLA for maintaining hemostasis when suturing the proximal anastomosis. Patients will be followed for any clinical events at 6 weeks and 9 months post surgery.

Conditions

Interventions

DEVICE

VIOLA proximal seal

VIOLA proximal seal system for maintenance of hemostasis when suturing the aortic anastomoses

Sponsors & Collaborators

  • Vascular Graft Solutions Ltd.

    lead INDUSTRY

Principal Investigators

  • Gil Bolotin, MD · Rambam Health Care Campus

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-05
Primary Completion
2024-01-09
Completion
2024-07-16

Countries

  • Israel

Study Locations

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Entities

Diseases

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 NCT05914246 on ClinicalTrials.gov