Aortic AneurysmCLOSURENCT06918496
Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
A study testing Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair. in people with Aortic Aneurysm and Aortic Aneurysm Abdominal, run by Grena Biomed Limited at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Valve Stenoses, Aortic
- What is being tested?
- Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Jun 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Belgium1 site
Jessa Hospital
Hasselt, Limburg, 3500
Dr. Bert Du Pont
Dr. Bert Du Pont
Poland1 site
Klinika Kardiochirurgii i Transplantologii
Warsaw, 04-628
Dr. Piotr Kołsut
Dr. Piotr Kołsut
About this study
Official title: 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.
Read the 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 the need for reoperation, which has high mortality rates. Blood transfusions carry risks, and patients who avoid them tend to recover better. Advances in surgical techniques and the use of anticoagulants have increased the need for robust methods to prevent suture line bleeding.
Surgical adhesives are becoming standard practice to prevent air and liquid leaks during surgeries. Different classes of adhesives, such as cyanoacrylates, polyethylene glycol polymers, bovine serum albumin (BSA) and glutaraldehyde mixtures, gelatin and thrombin sealants, and fibrin sealants, offer various advantages and disadvantages.
Most cyanoacrylate sealants are used externally due to risks of infection, cytotoxicity, and tissue necrosis when used internally. They are effective for closing skin incisions, trauma wounds, and providing a microbial barrier over closed wounds. Polyethylene glycol hydrogel adhesives are valued for their biocompatibility, degradability, and tunable mechanical properties, acting as both fluid barriers and hemostatic agents. However, they can cause significant post-polymerization swelling. Fibrin sealants, derived from blood, are used as hemostatic agents in cardiac, liver, and splenic surgeries. They carry risks of transmitting infections and air or gas embolism. Gelatin and thrombin mixtures are versatile hemostatic agents used in various surgeries, including delicate structures like nerves, due to their low toxicity.
The last class of surgical adhesives includes mixtures of bovine serum albumin (BSA) and glutaraldehyde (GA) or polyaldehyde. In BioGlue® (CryoLife Inc.) and PREVELEAKTM (Baxter Advanced Surgery), BSA crosslinks with extracellular proteins to form a mechanical seal independent of the coagulation system. NE'X Glue R-eco, a new adhesive by Grena BioMed Limited, is similar to BioGlue® but uses recombinant human serum albumin (rHSA) instead of BSA. Both adhesives use a double-chambered syringe for controlled application.
BioGlue® has proven biocompatibility, reliability, and safety, with minor differences in external shape compared to NE'X Glue R-eco. BioGlue® has passed extensive biological evaluations and animal studies, demonstrating its effectiveness in surgical repairs.
Analytical and functional tests have shown that NE'X Glue R-eco has adequate bonding strength and similar chemical properties to BioGlue®. The safety and benefits of these adhesives have been demonstrated in various studies. This pivotal study aims to evaluate the efficacy and safety of NE'X Glue R-eco for sealing suture lines. The study will assess immediate and delayed suture line sealing, sealing time, use of additional agents, product handling, blood loss, use of blood replacement products, anticoagulant/antiplatelet medication intake, device deficiencies, and peri- and postoperative complications and re-interventions.
The primary objective of this study is to evaluate the immediate sealing of suture lines using NE'X Glue R-eco. The secondary objective is to assess the overall efficacy and safety of NE'X Glue R-eco for prophylactic suture line sealing.
This clinical investigation uses a single-arm, non-randomized design to evaluate the safety and effectiveness of surgical adhesives in cardiac and vascular procedures. Strict inclusion and exclusion criteria prevent bias, ensuring participants represent the general population needing these surgeries. Exclusion criteria include hypersensitivity, active infection, vasculitis, bleeding disorders, immune suppression, and refusal of blood transfusions. Clinical Research Associates will monitor the study and report any deviations.
Participants will be followed for up to 3 months post-surgery to document potential complications such as inflammatory responses, allergic reactions, tissue necrosis, vessel obstruction, thrombosis, and more. This follow-up period allows for clear documentation of safety and effectiveness.
Patients undergoing large vessel and cardiac repair, arterial reconstruction, or arteriovenous graft formation with prosthetic or biologic grafts (patches) or allografts will be included in this study. Data will be collected from 60 patients at sites in Belgium and Poland. Inclusion and exclusion criteria ensure a diverse participant cohort reflective of the broader population. Minors, pregnant women, and breastfeeding women are excluded. Female participants of childbearing age must use contraception and undergo pregnancy testing. Incapacitated patients may be included if their medical condition prevents informed consent. Follow-up monitoring will be conducted for up to 3 months post-procedure.
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Valve Stenoses, Aortic, Valve Regurgitation, Mitral, Valve Regurgitation, Tricuspid, Aneurysm of Ascending Aorta
- Being tested
- Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.
- Keywords
- prophylactic sealing of suture lines, Surgical glue, cardiac and (cardio)vascular anastomotic repair procedures, grafts, NE'X Glue R-eco surgical adhesive
- Medical subject headings
- Aortic Aneurysm, Aortic Aneurysm, Abdominal, Aortic Valve Stenosis, Mitral Valve Insufficiency, Tricuspid Valve Insufficiency, Aneurysm, Ascending Aorta, Peripheral Arterial Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
The cases where the investigator choses to intervene and use additional methods to achieve hemostasis will be defined as 'bleeding'. For patients with more than one anastomotic site treated, the site with the longest time to hemostasis was used for these analyses. If fast flow or spurting, the surgeon may use additional agents for hemostasis before the 10 minutes are up to guarantee the safety of the patient.
Measured: During the index-procedure
To determine the elapsed time from clamp release to hemostasis (sealing time) recorded per site.
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'.
Anastomoses where the investigator choses to intervene and use additional methods to achieve hemostasis will not be included in this analysis. Any time to hemostasis that was >10 minutes was treated as 10 minutes in the analysis.
Measured: 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).
For patients with more than one anastomotic site treated, each patient will be classified as having had an additional agent or not.
Measured: During the index-procedure
To determine the product handling and performance of NE'X Glue R-eco
By documenting the following outcomes, using the following four possible responses: excellent, good, fair or poor.
- Ease of preparing
- Performance of the delivery system
- Gel rate
- Adhesiveness
Measured: During the index-procedure
To determine device deficiencies
These device deficiencies may include, but are not limited to
- Failure of adhesive to adhere to tissue
- Failure of sealing
- Device malfunction
Measured: During the index-procedure
To determine blood loss during the first 24-48 hours post-surgery
Estimated blood loss by visual inspection or gravimetric method.
Measured: During the first 24-48 hours post-surgery (post index-procedure)
To determine the intake of anticoagulant/antiplatelet medication
The intake will be documented at screening, index-procedure, discharge, 5 weeks follow-up and 3 months follow-up.
Measured: From screening until end of participation in the study at 3 months
To determine the intra-operative and post-operative complication rate
Complications may include, but are not limited to:
- Hypersensitivity reaction such as swelling or edema at the application site
- Application of adhesive to tissue not targeted for procedure resulting in a complication
- Local tissue necrosis
- Mineralization of tissue
- Infection
- Thrombosis and thromboembolism
- Intra- and post-operative significant bleeding, defined as a steady stream of blood that would not resolve without intervention
- Ischemia
- Myocardial infarction
- Neurological deficit
- Organ system failure
- Paraplegia
- Renal dysfunction/failure
- Respiratory dysfunction/failure
- Stroke or cerebral infarction
- Other complications related to cardiac and (cardio)vascular procedures
Measured: From index-procedure until end of participation in the study at 3 months
Return to the operating room (re-interventions) within 3 months.
Measured: From index-procedure until end of participation in the study at 3 months
Mortality / Decease
Measured: From index-procedure until end of participation in the study at 3 months
To determine the use of any blood replacement products
Type and quantity will be documented
Measured: From index-procedure until end of participation in the study at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start30 Jun 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-market, pivotal, commercial, prospective, single-arm, interventional, multicenter clinical investigation
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grena Biomed Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Archer Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918496
- Sponsor's protocol ID
- CIV-24-12-050294
- Acronym
- CLOSURE
- Status last verified
- Apr 2025
- First submitted
- 21 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06918496
- Acronym / sponsor ID
- CLOSURE / CIV-24-12-050294
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Valve Stenoses, Aortic, Valve Regurgitation, Mitral, Valve Regurgitation, Tricuspid, Aneurysm of Ascending Aorta
- Keywords
- prophylactic sealing of suture lines, Surgical glue, cardiac and (cardio)vascular anastomotic repair procedures, grafts, NE'X Glue R-eco surgical adhesive
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Grena Biomed LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Archer Research
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 the need for reoperation, which has high mortality rates. Blood transfusions carry risks, and patients who avoid them tend to recover better. Advances in surgical techniques and the use of anticoagulants have increased the need for robust methods to prevent suture line bleeding.
Surgical adhesives are becoming standard practice to prevent air and liquid leaks during surgeries. Different classes of adhesives, such as cyanoacrylates, polyethylene glycol polymers, bovine serum albumin (BSA) and glutaraldehyde mixtures, gelatin and thrombin sealants, and fibrin sealants, offer various advantages and disadvantages.
Most cyanoacrylate sealants are used externally due to risks of infection, cytotoxicity, and tissue necrosis when used internally. They are effective for closing skin incisions, trauma wounds, and providing a microbial barrier over closed wounds. Polyethylene glycol hydrogel adhesives are valued for their biocompatibility, degradability, and tunable mechanical properties, acting as both fluid barriers and hemostatic agents. However, they can cause significant post-polymerization swelling. Fibrin sealants, derived from blood, are used as hemostatic agents in cardiac, liver, and splenic surgeries. They carry risks of transmitting infections and air or gas embolism. Gelatin and thrombin mixtures are versatile hemostatic agents used in various surgeries, including delicate structures like nerves, due to their low toxicity.
The last class of surgical adhesives includes mixtures of bovine serum albumin (BSA) and glutaraldehyde (GA) or polyaldehyde. In BioGlue® (CryoLife Inc.) and PREVELEAKTM (Baxter Advanced Surgery), BSA crosslinks with extracellular proteins to form a mechanical seal independent of the coagulation system. NE'X Glue R-eco, a new adhesive by Grena BioMed Limited, is similar to BioGlue® but uses recombinant human serum albumin (rHSA) instead of BSA. Both adhesives use a double-chambered syringe for controlled application.
BioGlue® has proven biocompatibility, reliability, and safety, with minor differences in external shape compared to NE'X Glue R-eco. BioGlue® has passed extensive biological evaluations and animal studies, demonstrating its effectiveness in surgical repairs.
Analytical and functional tests have shown that NE'X Glue R-eco has adequate bonding strength and similar chemical properties to BioGlue®. The safety and benefits of these adhesives have been demonstrated in various studies. This pivotal study aims to evaluate the efficacy and safety of NE'X Glue R-eco for sealing suture lines. The study will assess immediate and delayed suture line sealing, sealing time, use of additional agents, product handling, blood loss, use of blood replacement products, anticoagulant/antiplatelet medication intake, device deficiencies, and peri- and postoperative complications and re-interventions.
The primary objective of this study is to evaluate the immediate sealing of suture lines using NE'X Glue R-eco. The secondary objective is to assess the overall efficacy and safety of NE'X Glue R-eco for prophylactic suture line sealing.
This clinical investigation uses a single-arm, non-randomized design to evaluate the safety and effectiveness of surgical adhesives in cardiac and vascular procedures. Strict inclusion and exclusion criteria prevent bias, ensuring participants represent the general population needing these surgeries. Exclusion criteria include hypersensitivity, active infection, vasculitis, bleeding disorders, immune suppression, and refusal of blood transfusions. Clinical Research Associates will monitor the study and report any deviations.
Participants will be followed for up to 3 months post-surgery to document potential complications such as inflammatory responses, allergic reactions, tissue necrosis, vessel obstruction, thrombosis, and more. This follow-up period allows for clear documentation of safety and effectiveness.
Patients undergoing large vessel and cardiac repair, arterial reconstruction, or arteriovenous graft formation with prosthetic or biologic grafts (patches) or allografts will be included in this study. Data will be collected from 60 patients at sites in Belgium and Poland. Inclusion and exclusion criteria ensure a diverse participant cohort reflective of the broader population. Minors, pregnant women, and breastfeeding women are excluded. Female participants of childbearing age must use contraception and undergo pregnancy testing. Incapacitated patients may be included if their medical condition prevents informed consent. Follow-up monitoring will be conducted for up to 3 months post-procedure.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-market, pivotal, commercial, prospective, single-arm, interventional, multicenter clinical investigation
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Device: Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Single-arm |
Primary outcome
Evaluate immediate suture line sealing using NE'X Glue R-eco.
Time frame: From index-procedure until end of participation in the study at 3 months
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.
11 secondary outcomes
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).
Time frame: During the index-procedure
To determine the elapsed time from clamp release to hemostasis (sealing time) recorded per site.
Time frame: 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).
Time frame: During the index-procedure
To determine the product handling and performance of NE'X Glue R-eco
Time frame: During the index-procedure
To determine device deficiencies
Time frame: During the index-procedure
To determine blood loss during the first 24-48 hours post-surgery
Time frame: During the first 24-48 hours post-surgery (post index-procedure)
To determine the intake of anticoagulant/antiplatelet medication
Time frame: From screening until end of participation in the study at 3 months
To determine the intra-operative and post-operative complication rate
Time frame: From index-procedure until end of participation in the study at 3 months
Return to the operating room (re-interventions) within 3 months.
Time frame: From index-procedure until end of participation in the study at 3 months
Mortality / Decease
Time frame: From index-procedure until end of participation in the study at 3 months
To determine the use of any blood replacement products
Time frame: From index-procedure until end of participation in the study at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair. in people with Aortic Aneurysm and Aortic Aneurysm Abdominal, run by Grena Biomed Limited at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorien Haesen, PhD (+32 11 286927, dorien.haesen@archerresearch.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate immediate suture line sealing using NE'X Glue R-eco. (time frame: From index-procedure until end of participation in the study at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.