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Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery

NCT06918496 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-09

No results posted yet for this study

Summary

This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a prosthetic or biologic graft, patch, or allograft.

The effectiveness of the adhesive will be assessed after restoring blood flow.

Conditions

  • Aortic Aneurysm
  • Aortic Aneurysm Abdominal
  • Valve Stenoses, Aortic
  • Valve Regurgitation, Mitral
  • Valve Regurgitation, Tricuspid
  • Aneurysm of Ascending Aorta
  • Aneurysm Abdominal
  • Artery Diseases, Peripheral
  • Ventricular Aneurysm
  • Coronary Artery Disease
  • Valve Aortic Regurgitation
  • Aortic Aneurysms Arch
  • Aortic Aneurysms Descending
  • Aortic Aneurysms Thoracoabdominal

Interventions

DEVICE

Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.

Suture line bleeding in cardiac and vascular reconstruction poses significant risks, including morbidity, mortality, and complications related to blood loss and transfusion. Advances in surgical techniques have improved hemostasis but may not suffice, especially in patients on anticoagulant or antiplatelet medications or those using synthetic graft materials. Surgical adhesives are valuable adjuncts to standard hemostatic techniques, aiming to prevent postoperative bleeding and its associated complications. NE'X Glue R-eco, a novel surgical adhesive, utilizes recombinant human serum albumin (rHSA) and glutaraldehyde (GA) for suture line sealing. It is similar to BioGlue®, which uses bovine serum albumin (BSA) and GA, and has proven safety and benefits. Distinguishing Features of NE'X Glue R-eco: Composition: Uses rHSA expressed in plants, offering improved biocompatibility and reduced risk of allergic reactions. Bonding Strength: Demonstrates high bonding strength in tests, comparab

Sponsors & Collaborators

  • Archer Research

    collaborator INDUSTRY

  • Grena Biomed Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Belgium
  • Poland

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 NCT06918496 on ClinicalTrials.gov