Status:
NOT_YET_RECRUITING
Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
Lead Sponsor:
Grena Biomed Limited
Collaborating Sponsors:
Archer Research
Conditions:
Aortic Aneurysm
Aortic Aneurysm Abdominal
Eligibility:
All Genders
18+ years
Phase:
NA
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 v...
Detailed Description
Suture line bleeding is a common issue in cardiovascular surgeries, leading to serious complications and increased costs. Effective management is crucial to prevent morbidity, fatal consequences, and ...
Eligibility Criteria
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 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.
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06918496
Start Date
June 30 2025
End Date
March 31 2026
Last Update
April 9 2025
Active Locations (2)
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1
Jessa Hospital
Hasselt, Limburg, Belgium, 3500
2
Klinika Kardiochirurgii i Transplantologii
Warsaw, Poland, 04-628