Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery (NCT06918496) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
Belgium, Poland60 participantsStarted 2025-06-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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., intr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate immediate suture line sealing using NE'X Glue R-eco.
Timeframe: From index-procedure until end of participation in the study at 3 months