IEIK13 For Neurosurgery | NCT04953949

Studies
IEIK13 For Neurosurgery

NCT04953949

Sponsor

3-D Matrix Europe SAS

Status

Completed

Last Update Posted

Nov 18, 2023Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Oozing (Hemorrhage) During Intracranial Procedures

Interventions

NU-MAX®

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 6, 2021Actual

Primary Completion Date

Aug 4, 2023Actual

Completion Date

Nov 4, 2023Actual

First Submitted Date

Jun 29, 2021

First Submission Date that Met QC Criteria

Jun 29, 2021

First Posted Date

Jul 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2023

Last Update Posted Date

Nov 18, 2023Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Label	Type	Description	Intervention Names
NU-MAX®	Experimental	Topical Hemostat	Device: NU-MAX®

Name	Type	Description	Arm Group Labels	Other Names
NU-MAX®	Device	Topical Hemostat	NU-MAX®

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms