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

NCT06918496 | Not Yet Recruiting

• 1 other identifier: CIV-24-12-050294
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

prophylactic sealing of suture lines; Surgical glue; cardiac and (cardio)vascular anastomotic repair procedures; grafts; NE'X Glue R-eco surgical adhesive

Outcome Measures

Primary Outcomes (1)

• Evaluate immediate suture line sealing using NE'X Glue R-eco.

  Proportion of patients/anastomoses with immediate suture line sealing by NE'X Glue R-eco, evidenced by lack of clinically significant bleeding (bleeding status is 'No bleeding' or 'Oozing'), as judged by the surgeon immediately after clamp release. Clamp release is performed 2 minutes after the application of the adhesive. Bleeding is classified into one of four categories: 1. No bleeding, 2. Oozing, 3. Fast flow, 4. Spurting, where 1 and 2 will be considered as 'no clinically significant bleeding' and 3 and 4 as 'bleeding'. Sealing time refers to the time the anastomotic site is completely sealed, that is, the last time point in which bleeding status equaled 'No bleeding' and 'Oozing'. Immediate sealing means the sealing time is 0. For patients with multiple anastomoses, immediate suture line sealing should occur in all for the patient to have no clinically significant bleeding at sealing time 0.

  From index-procedure until end of participation in the study at 3 months

Secondary Outcomes (11)

• To determine the proportion of patients/anastomoses with suture line sealing using NE'X Glue R-eco, measured at 1, 3, 5, and 10 minutes after clamp release (timed with a calibrated stop watch).

  During the index-procedure

• To determine the elapsed time from clamp release to hemostasis (sealing time) recorded per site.

  During the index-procedure

• To determine the use of any additional methods to achieve hemostasis (including pledgets, sutures, hemostatic devices, antifibrinolytic agents, thrombin glues, fibrin glues, etc.) (type and quantity).

  During the index-procedure

• To determine the product handling and performance of NE'X Glue R-eco

  During the index-procedure

• To determine device deficiencies

  During the index-procedure

Study Arms (1)

Single-arm

EXPERIMENTAL

A single-arm design is selected, providing data about safety and clinical effectiveness of the NE'X Glue R-eco of which are to be compared to established data available in the literature

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

Interventions

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

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

Single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥ 18 years of age at study entry.
• Patient is scheduled for open procedures for surgical placement of a prosthetic or biologic graft (patch) or an allograft for cardiac and (cardio)vascular anastomosis repair. Emergency, transplantation and minimally invasive procedures are excluded. Patients receiving long-term anticoagulation, including antiplatelet agent, are included. Choice of graft is at the discretion of the surgeon.
• Patient is willing and able to be contacted for up to 3 months (± 14 days) follow-up.
• Patient or legal representative and investigator signed and dated the informed consent form prior to the index-procedure.

You may not qualify if:

• Patient has a known hypersensitivity, contraindication, or allergic reaction to albumin or glutaraldehyde.
• Patient has a history of bleeding diathesis or coagulopathy.
• Presence of active infection or contamination in the to be grafted area or the vicinity.
• Known vasculitis in the to be grafted area.
• Patient takes immune suppressive medication like prednisone resulting in weakening of the vessel wall.
• Patient is refusing blood transfusion.
• Patient or legal representative is unable / unwilling to provide informed consent.
• Patient is unable to comply with the protocol or proposed follow-up visits.
• Female patient is pregnant, lactating, or planning pregnancy during the clinical investigation.
• Female participants of childbearing age must agree to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release, abstinence).
• Patients who are currently enrolled in another clinical study, or have recently participated in a clinical study, that could potentially interfere with the outcomes or introduce bias into the results of the current study (as determined by the investigator). This includes studies involving investigational drugs, medical devices, or other interventions that could impact the safety, efficacy, or scientific integrity of this study.

Sponsors & Collaborators

• Grena Biomed Limited: lead
• Archer Research: collaborator

Study Sites (2)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

Location

Klinika Kardiochirurgii i Transplantologii

Warsaw, 04-628, Poland

Location

MeSH Terms

Conditions

Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Valve Stenosis; Mitral Valve Insufficiency; Tricuspid Valve Insufficiency; Aneurysm, Ascending Aorta; Peripheral Arterial Disease; Coronary Artery Disease; Aortic Valve Insufficiency; Aneurysm, Aortic Arch; Aortic Aneurysm, Thoracoabdominal

Interventions

Transdermal Patch

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Ventricular Outflow Obstruction; Aortic Aneurysm, Thoracic; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Coronary Disease; Myocardial Ischemia

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

Dorien Haesen, PhD

CONTACT

+32 11 286927; dorien.haesen@archerresearch.eu

Frea Coun

CONTACT

+32 11 286927; frea.coun@archerresearch.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pre-market, pivotal, commercial, prospective, single-arm, interventional, multicenter clinical investigation

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 9, 2025
• Study Start: June 30, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

PL (1); BE (1)