Oozing (Hemorrhage) During Intracranial ProceduresNCT04953949
IEIK13 For Neurosurgery
A study testing NU-MAX® in people with Oozing (Hemorrhage) During Intracranial Procedures, run by 3-D Matrix Europe SAS at 1 site in Belgium.
Trial summary
The objective of this clinical investigation is to determine the performance and safety profile of NU-MAX® when used as a topical hemostat for oozing bleedings encountered during intracranial procedures, in which control of bleeding by conventional hemostatic techniques is either ineffective or impractical. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oozing (Hemorrhage) During Intracranial Procedures
- What is being tested?
- NU-MAX®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Aug 2021to 4 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Have been informed on the nature of the clinical investigation and provided written informed consent, prior to initiation of any study activities.
- Able and willing to comply with the clinical investigation follow-up schedule.
- Male or female human subjects aged 18 years or older at time of enrollment.
- Requiring hemostasis during elective intracranial procedures, in which the intradural space is accessed and where the control of bleeding by conventional hemostatic techniques is either ineffective or impractical.
- NU-MAX® is used at least once intraoperatively.
Who cannot join
- Patients undergoing emergency craniotomy for traumatic lesions or patients undergoing surgery for primary intracranial hemorrhage.
- Patients undergoing surgical procedures using a transsphenoidal approach.
- Intraoperative use of a different topical chemical hemostatic agent prior to the use of NU-MAX® during the same procedure and on the same bleeding point or in the same resection cavity.
- Patients with a coagulation disorder or medical treatment affecting coagulation or platelet function, unless corrected or stopped prior to surgery.
- Pregnant patients or patients planning to become pregnant during the clinical investigation.
- Patients with known allergies to any of the components of NU-MAX®.
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- Patients currently participating in, or having been recently exited from (within 30 days from enrollment in this clinical investigation), or planning to enroll in another clinical investigation that may impact participation or outcomes (at the discretion of the sponsor) of this clinical investigation.
- Patients with a condition, disorder, or other factor that, in the investigator's opinion, would interfere with study participation.
- Fever (body temperature >38.5°C) prior to surgery, on the day of the procedure.
- Patients with a Nickel allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First-in-Human Trial of the Safety and Performance of NU-MAX® (IEIK13) as a Hemostatic Agent in Intracranial Neurosurgery
The objective of this clinical investigation is to determine the performance and safety profile of NU-MAX® when used as a topical hemostat for oozing bleedings encountered during intracranial procedures, in which control of bleeding by conventional hemostatic techniques is either ineffective or impractical.
- Being tested
- NU-MAX®
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NU-MAX®Device
Topical Hemostat
| Study group | Role | What they receive |
|---|---|---|
| NU-MAX® | Experimental | Topical Hemostat Receives: Device: NU-MAX® |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of bleedings reaching hemostasis within 3 minutes
The percentage of bleedings reaching hemostasis within 3 minutes will be measured intraoperatively after the use of NU-MAX® (with a maximum of 3 measurements of hemostasis by NU-MAX® application per subject).
Measured: Intraoperatively
Secondary outcomes (1)
% of bleedings reaching hemostasis within 6 minutes
The percentage of bleedings reaching hemostasis within 6 minutes will be measured intraoperatively after the use of NU-MAX® (up to 3 measurements per subject).
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start6 Aug 2021
- Primary completion4 Aug 2023
- Study completion4 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oozing (Hemorrhage) During Intracranial ProceduresStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single arm, multi-center study
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3-D Matrix Europe SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953949
- Sponsor's protocol ID
- IEIK13-01
- Status last verified
- Nov 2023
- First submitted
- 29 Jun 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human Trial of the Safety and Performance of NU-MAX® (IEIK13) as a Hemostatic Agent in Intracranial Neurosurgery
- ClinicalTrials.gov ID
- NCT04953949
- Acronym / sponsor ID
- IEIK13-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- 3-D Matrix Europe SASIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 4 Nov 2023 (actual)
- First posted
- 8 Jul 2021 (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.
The objective of this clinical investigation is to determine the performance and safety profile of NU-MAX® when used as a topical hemostat for oozing bleedings encountered during intracranial procedures, in which control of bleeding by conventional hemostatic techniques is either ineffective or impractical.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single arm, multi-center study
| Arm | Type | Receives |
|---|---|---|
| NU-MAX® | Experimental | Device: NU-MAX®Topical Hemostat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have been informed on the nature of the clinical investigation and provided written informed consent, prior to initiation of any study activities.
- Able and willing to comply with the clinical investigation follow-up schedule.
- Male or female human subjects aged 18 years or older at time of enrollment.
- Requiring hemostasis during elective intracranial procedures, in which the intradural space is accessed and where the control of bleeding by conventional hemostatic techniques is either ineffective or impractical.
- NU-MAX® is used at least once intraoperatively.
Key exclusion criteria (10 listed)
- Patients undergoing emergency craniotomy for traumatic lesions or patients undergoing surgery for primary intracranial hemorrhage.
- Patients undergoing surgical procedures using a transsphenoidal approach.
- Intraoperative use of a different topical chemical hemostatic agent prior to the use of NU-MAX® during the same procedure and on the same bleeding point or in the same resection cavity.
- Patients with a coagulation disorder or medical treatment affecting coagulation or platelet function, unless corrected or stopped prior to surgery.
- Pregnant patients or patients planning to become pregnant during the clinical investigation.
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 |
|---|---|---|
| NU-MAX®Topical Hemostat | Device | NU-MAX® |
Primary outcome
% of bleedings reaching hemostasis within 3 minutes
Time frame: Intraoperatively
The percentage of bleedings reaching hemostasis within 3 minutes will be measured intraoperatively after the use of NU-MAX® (with a maximum of 3 measurements of hemostasis by NU-MAX® application per subject).
1 secondary outcome
% of bleedings reaching hemostasis within 6 minutes
Time frame: Intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NU-MAX® in people with Oozing (Hemorrhage) During Intracranial Procedures, run by 3-D Matrix Europe SAS at 1 site in Belgium.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of bleedings reaching hemostasis within 3 minutes (time frame: Intraoperatively). 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 18 Nov 2023.