IEIK13 For Neurosurgery

Study Overview
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Brief Summary
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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.

Official Title
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First-in-Human Trial of the Safety and Performance of NU-MAX® (IEIK13) as a Hemostatic Agent in Intracranial Neurosurgery

Conditions
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Oozing (Hemorrhage) During Intracranial Procedures

Intervention / Treatment
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* Device: NU-MAX®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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®. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single arm, multi-center study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NU-MAX®<br>Topical Hemostat | Device: NU-MAX®<br>* Topical Hemostat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % 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). | Intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % 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). | Intraoperatively |