IEIK13 For Neurosurgery

NCT04953949 | Completed DMC

• 1 other identifier: IEIK13-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oozing (Hemorrhage) During Intracranial Procedures

Outcome Measures

Primary Outcomes (1)

• % 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 Outcomes (1)

• % of bleedings reaching hemostasis within 6 minutes

  Intraoperatively

Study Arms (1)

NU-MAX®

EXPERIMENTAL

Topical Hemostat

Device: NU-MAX®

Interventions

NU-MAX® DEVICE

Topical Hemostat

NU-MAX®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• 3-D Matrix Europe SAS: lead

Study Sites (1)

Antwerp University Hospital (UZA)

Edegem, 2650, Belgium

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single arm, multi-center study

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 8, 2021
• Study Start: August 6, 2021
• Primary Completion: August 4, 2023
• Study Completion: November 4, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)