IEIK13 For Neurosurgery

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.

Study Overview

• Status: Completed
• Conditions: Oozing (Hemorrhage) During Intracranial Procedures
• Intervention / Treatment: Device: NU-MAX®

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Antwerp University Hospital (UZA)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Have been informed on the nature of the clinical investigation and provided written informed consent, prior to initiation of any study activities.
2. Able and willing to comply with the clinical investigation follow-up schedule.
3. Male or female human subjects aged 18 years or older at time of enrollment.
4. 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.
5. NU-MAX® is used at least once intraoperatively.

Exclusion Criteria:

1. Patients undergoing emergency craniotomy for traumatic lesions or patients undergoing surgery for primary intracranial hemorrhage.
2. Patients undergoing surgical procedures using a transsphenoidal approach.
3. 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.
4. Patients with a coagulation disorder or medical treatment affecting coagulation or platelet function, unless corrected or stopped prior to surgery.
5. Pregnant patients or patients planning to become pregnant during the clinical investigation.
6. Patients with known allergies to any of the components of NU-MAX®.
7. 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.
8. Patients with a condition, disorder, or other factor that, in the investigator's opinion, would interfere with study participation.
9. Fever (body temperature >38.5°C) prior to surgery, on the day of the procedure.
10. Patients with a Nickel allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NU-MAX®; Topical Hemostat	Device: NU-MAX®; Topical Hemostat

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 3-D Matrix Europe SAS

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2021
• Primary Completion (Actual): August 4, 2023
• Study Completion (Actual): November 4, 2023

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: IEIK13-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No