Tests a surgical glue to seal stitch lines in heart and blood vessel repair
Tests a surgical glue to seal stitches in adults having heart or vessel repair.
Plain-language title generated from the registry record
Registry title: Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
Key facts
- Where
- Hasselt, BelgiumSee the site
Where in Belgium
- Jessa HospitalHasselt, BelgiumNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Grena Biomed Limited
- Trial code
- NCT06918496
- Record updated
- 9 April 2025
- Original description
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.Read full original descriptionShow less
A Prospective ClinicaL investigatiOn Evaluating Prophylactic Sealing of sUture Lines Using the NE'X Glue R-eco Surgical AdhesivE in Cardiac and (Cardio)Vascular Anastomotic Repair Procedures
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.
Inclusion: 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.
Exclusion: Patient takes immune suppressive medication like prednisone resulting in weakening of the vessel wall; 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; Patient has a history of bleeding diathesis or coagulopathy; Presence of active infection or contamination in the to be grafted area or the vicinity; Patient has a known hypersensitivity, contraindication, or allergic reaction to albumin or glutaraldehyde; 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); Known vasculitis in the to be grafted area; 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.