IEIK13 For Neurosurgery
Research type
Research Study
Full title
First-in-Human Trial of the Safety and Performance of NU-MAX® (IEIK13) as a Hemostatic Agent in Intracranial Neurosurgery
IRAS ID
290871
Contact name
Florian Rebeca
Contact email
Sponsor organisation
3-D Matrix Europe SAS
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
Research Summary: The IEIK13 (NU-MAX®) Study is a prospective, single-arm, multi-center study of NU-MAX® as a topical hemostatic agent used during intracranial procedures. This is a first-in-human clinical investigation aimed at evaluating the safety and performance of NU-MAX® when used according to the indication for use. All subjects eligible for participation in this clinical investigation will receive NU-MAX® as a topical hemostat during an elective intracranial procedure, in case of resection bed oozing or venous capillary bleedings, in which control of bleeding by conventional hemostatic techniques is either deemed ineffective or impractical. To determine the safety and performance of NU-MAX®, a single-arm study was deemed appropriate.
NU-MAX® will be tested in multiple hospitals across Europe and the United Kingdom. The collection of data of around 80 participants will allow determining the performance and safety of NU-MAX® to stop bleedings during brain surgery. Participation in the trial is expected to last approximately 3 to 4 months for each participant. The surgical procedure and subsequent follow-up visits after surgery will be performed according to the standard of care at the hospitals. Participants will be evaluated one day after surgery, at discharge and 30 days and 3 months after surgery.
The clinical investigation will be split into 2 stages: Stage I will enrol a small cohort of subjects within which the initial safety of NU-MAX® will be evaluated, after which the enrolment into the clinical investigation will be paused. Re-opening of recruitment will only be triggered by authorization to proceed from a committee of experts. Stage II of the clinical investigation will evaluate the performance and safety of NU-MAX® in a wider group of subjects (i.e. the remaining estimated 70 subjects).
Summary of Results:
Hemostasis is a prerequisite in neurosurgery to keep adequate visual control during the operation and to prevent post-operative hemorrhage. Additionally, sustained performance is critical as any rebleeding can cause complications which are critical because of the severity of adverse effects. However, available hemostats have limitations and there is no golden standard available.NU-MAX is indicated 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.
This clinical investigation aimed to recruit 80 subjects (160 bleedings), divided in 5 investigational centres in Europe, to assess the safety and performance of NU-MAX. The final number of screened subjects was 88 subjects, of which 80 subjects and 203 bleedings were treated with NU-MAX.
The percentage of bleedings of the PP (Per Protocol) population and ITT (Intent-to-Treat) population that reached hemostasis within 3 minutes was 94.2% and 94.1% respectively (primary endpoint). The primary performance endpoint exceeded the hypothesized performance (P<0.001). A subgroup analysis by severity of bleeding showed that the primary endpoint was achieved in 98.9% and 93.9% of respectively mild and moderate bleedings, and in lower extent in severe bleedings (64.3%; PP population).Another subgroup analysis by the source of bleedings showed that in 86.1% of arterial bleedings, 94% of venous bleedings, 98.4% of capillary bleedings and 100% of mixed bleedings hemostasis was achieved within 3 minutes after the use of NU-MAX.
The percentage of bleedings of the PP population and ITT population that reached hemostasis within 6 minutes was 95.8% and 95.6% respectively (secondary endpoint). Likewise to the primary performance endpoint, hemostasis was achieved within 6 minutes in the majority of mild and moderate bleedings (> 90%; 98.9% and 96.3% respectively), and in 71.4% (10/14) of severe bleedings. Although lower hemostatic performance within 6 min is observed for severe bleedings, the outcome is still clinically relevant for controlling such ‘heavy’ bleedings. Surgeons were highly satisfied by the hemostatic properties of NU-MAX and would consider using NU-MAX again and routinely in their practice.
The occurrence of safety events was lower or comparable to state of the art literature and therefore deemed acceptable. No safety concerns were identified.
Overall, it can be concluded that NU-MAX has a good performance and safety profile when used as intended. In addition, the use of NU-MAX does not seem to impede the use of other hemostatic agents or techniques during the same procedure.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0249
Date of REC Opinion
6 Jan 2022
REC opinion
Further Information Favourable Opinion