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A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair. (NEOART)

Primary Purpose

Dural Tear, Cerebrospinal Fluid Leak

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Implantation of the ArtiFascia®
Implantation of other commercial suturable dural substitute
Sponsored by
Nurami Medical Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dural Tear

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject between the ages of 18-75
  2. Subject is scheduled for an elective cranial surgery with a dural damage that can be completely repaired/closed by a suture-able dural substitute (ArtiFascia device or other commercially available dural substitutes)
  3. Subject has undergone radiographic imaging (such as, MRI) in the past 6 months before enrolment
  4. Surgical wound is expected to be Class I/clean
  5. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
  6. Subject is able and willing to adhere to the required follow-up visits and testing

Exclusion Criteria:

  1. Pregnant women or interest in becoming pregnant during the duration of the study
  2. Subject has known hydrocephalus
  3. Subject is unable to undergo MRI after the surgery
  4. Subject's life expectancy is less than 12 months
  5. Subject has a local or systemic infection (e.g. urinary tract infection (UTI), active pneumonia) or evidence of any surgical site infection, fever > 38.3℃, positive blood culture and/or a positive chest x-ray for acute infectious process
  6. Subject will require use of dural adhesive or sealant
  7. Subject is intended to undergo craniectomy wherein bone flap will not be returned
  8. Subject with suspected low success in wound healing due to past treatments (e.g. chemotherapy, radiation therapy, severe diabetes etc.) or other conditions (e.g. severe peripheral vascular disease, long standing steroids treatment)
  9. Subject has been clinically diagnosed with malignancy (other than basal cell carcinoma or low-grade glioma), uncontrolled diabetes (A1C>6.5%), sepsis, systemic collagen disease.
  10. Subject had chemotherapy and/or radiotherapy in the past 12 weeks before surgery or is planned to have chemotherapy or radiotherapy less than 12 weeks after surgery.
  11. Subject is an acute cranial trauma surgical case
  12. Subjects with a concurrent disease that would place the patient in excessive risk to the planned surgery
  13. Subject had a previous neurosurgery in the same anatomical site
  14. Subject with other undesirable symptoms defined by the principal investigator
  15. Patient has clinically significant coagulopathy as determined by the surgeon
  16. Subject is participating in another clinical trial using similar investigational devices/drugs

Sites / Locations

  • Ziekenhuis Oost-Limburg
  • St. Anne's University Hospital Brno
  • Neurochirurgická klinika Přednosta FN Olomouc
  • Rabin Medical Center (Beilinson, Hasharon)
  • Medical University of Gdańsk
  • Barlicki University Hospital
  • Hospital Universitari Vall d'Hebron
  • Hospital Clinic de Barcelona
  • Hospital Universitario de Bellvitge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment arm

Control

Arm Description

Procedure will be performed under general anaesthesia. The patients will undergo a surgery that is identical to the one that was planned by the surgeon. At the end of the surgery, the investigator will use the ArtiFascia® patch. Implantation of the ArtiFascia® will be according to clinical discretion of the physician, and in compliance with ArtiFascia® instructions for use. Detailed instructions are in the instructions for use. Post operation the subject will stay at the hospital according to site standards and physician discretion.

Same procedure as for the treatment arm but using a commercial suturable dural substitute. Implantation of the commercial suturable dural substitute will be according to clinical discretion of the physician, and in compliance with each specific device instructions for use. Detailed instructions are in the instructions for use.

Outcomes

Primary Outcome Measures

Assess the safety and effectiveness of ArtiFascia® in comparison with commercially available suturable dural substitutes in subjects requiring Dural repair following neurosurgery
Safety and effectiveness will be assessed by evaluating the absence of CSF fistula (drainage from wound or sinus) and pseudo-meningocele post-operative as evaluated by MRI imaging. During MRI imaging CSF leakage will be assessed as: none/external leakage/subgaleal leakage. Additional if leakage is present, severity will be reported (mild/moderate/severe).

Secondary Outcome Measures

Wound healing assessment
Clean and/or fully healed vs. Infected. Evaluation of wound will be done in physical examination: clean and/or fully healed/ infected. If wound is infected additional assessment of mild/moderate/severe will be done.
Device Handling Characteristics
Based on scale to evaluate device: Suturing, seal quality, strength, ease of use (Score from 1=easy to 5=difficult).
Radiographic evaluation (Magnetic Resonance Imaging).
To determine the presence or absence of the following measure: adhesion formation, new tissue formation, pseudomeningocele, extracerebal fluid collection and brain edema adjacent to device implant size Measurements will be done based on MRI imaging (X,Y,Z axis; in milimeters).

Full Information

First Posted
October 21, 2019
Last Updated
November 7, 2022
Sponsor
Nurami Medical Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04145544
Brief Title
A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair.
Acronym
NEOART
Official Title
A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes- NEOART Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nurami Medical Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to evaluate the safety and effectiveness of ArtiFascia® in comparison with commercially available dural substitutes in patients requiring Dural repair following neurosurgery. Patients with planned cranial neurosurgery can take part in this study. During the surgery the soft membrane that covers the brain (called dura) is likely to be cut and damaged. A damaged dura can cause a leakage of brain fluids (cerebrospinal fluid [CSF] leakage) and increase the risk of infections. Sponsor of this study has developed the ArtiFascia®. ArtiFascia® is a medical synthetic dural substitute that is absorbed by the body. ArtiFascia® supports the re-formation of a new dura. In addition it has a sealant layer that can reduce CSF leakage and infection.
Detailed Description
A Prospective, randomized, controlled multi-center study of ArtiFascia® Dural repair patch compared with commercially available dural substitutes- NEOART Study. The dura mater is a fibrous connective tissue that surrounds the nervous system (brain and spinal cord) and provides a mechanical barrier that contains the cerebrospinal fluid (CSF). The dura mater may be damaged as a result of trauma or planned surgery. When dural defects cannot be repaired by primary closure, a dural substitute must be utilized in order to reduce CSF leakage. There are devices that have been used as dural substitutes. Among the devices that are based on natural raw materials, collagen-based matrices are widely used. Although collagen was proven to be biocompatible, using collagen-based materials still possess several limitations such as CSF leaks. Synthetic dural substitutes are also used to repair dura mater. The most widely used raw-material for these synthetic products are polyesters - resorbable and biocompatible polymers. There are several dural substitutes based on synthetic polyesters that were successfully tested pre-clinically as well as in human studies. Sponsor of this study has developed the ArtiFascia®. ArtiFascia® is a medical synthetic dural substitute that is absorbed by the body. Before the study, the patients will have their blood taken and they will undergo neurological assessment. If they are suitable to participate in the study, and agree to participate, they will be randomly allocated into one of the following groups: Experimental group (ArtiFascia® device); Control group (Other commercially available suturable dural substitutes). The patients will undergo a surgery that is identical to the one that was planned by the surgeon. At the end of the surgery, the investigator will use ArtiFascia® patch or standard dural substitute to repair the damaged Dura. ArtiFascia® graft will be placed in areas where the native dural layer was damaged or missing. ArtiFascia® will be applied via a routine and well-known procedure, using a suturing technique. After implantation, the porous fibrous structure of ArtiFascia® provides a scaffold, which enables infiltration of fibroblasts and cells from the intact tissue, ultimately replacing damaged dural tissue. The patch is expected to resorb within a few months and to be replaced by the native tissue with complete dural closure. During the surgery and until patient's release from the hospital the patient's health will be closely monitored. Before the discharge patients will have to undergo neurological examination. Patients will be obligated to attend the follow up visits after the surgery at the dates scheduled by the attending physician. At each of the visits physical and neurological examinations will be performed. Radiographic Evaluation (Magnetic Resonance Imaging) will be performed also 6 months post operation. A total of 90 patients will be enrolled and implanted with test or control device. Up to 10 centers in Europe and Israel are planned to participate in this study. The primary endpoint will be achieved when the final study subject has completed a 6-months follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dural Tear, Cerebrospinal Fluid Leak

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
Procedure will be performed under general anaesthesia. The patients will undergo a surgery that is identical to the one that was planned by the surgeon. At the end of the surgery, the investigator will use the ArtiFascia® patch. Implantation of the ArtiFascia® will be according to clinical discretion of the physician, and in compliance with ArtiFascia® instructions for use. Detailed instructions are in the instructions for use. Post operation the subject will stay at the hospital according to site standards and physician discretion.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Same procedure as for the treatment arm but using a commercial suturable dural substitute. Implantation of the commercial suturable dural substitute will be according to clinical discretion of the physician, and in compliance with each specific device instructions for use. Detailed instructions are in the instructions for use.
Intervention Type
Device
Intervention Name(s)
Implantation of the ArtiFascia®
Intervention Description
Following are the general instructions for use for the ArtiFascia®: Cut the ArtiFascia® to the required shape under aseptic conditions Apply ArtiFascia® to the damaged area Suture the ArtiFascia® in place Suture bites should be taken 2-3 millimeters from the edges of the implant. Either a running suture or interrupted stitches' technique may be used, depending on clinical conditions or surgeon's decision. Important Note: If clinically possible, do not use dural adhesive or sealants as it is an uncontrolled variable, that can influence the results.
Intervention Type
Device
Intervention Name(s)
Implantation of other commercial suturable dural substitute
Intervention Description
Implantation of the commercial suturable dural substitute will be according to clinical discretion of the physician, and in compliance with each specific device instructions for use. Detailed instructions are in the instructions for use
Primary Outcome Measure Information:
Title
Assess the safety and effectiveness of ArtiFascia® in comparison with commercially available suturable dural substitutes in subjects requiring Dural repair following neurosurgery
Description
Safety and effectiveness will be assessed by evaluating the absence of CSF fistula (drainage from wound or sinus) and pseudo-meningocele post-operative as evaluated by MRI imaging. During MRI imaging CSF leakage will be assessed as: none/external leakage/subgaleal leakage. Additional if leakage is present, severity will be reported (mild/moderate/severe).
Time Frame
The rate of adverse events, adverse device effects and device deficiencies will be assessed on a continuous basis from the baseline (following signing the ICF) through the study completion at 6 month.
Secondary Outcome Measure Information:
Title
Wound healing assessment
Description
Clean and/or fully healed vs. Infected. Evaluation of wound will be done in physical examination: clean and/or fully healed/ infected. If wound is infected additional assessment of mild/moderate/severe will be done.
Time Frame
6 month follow-up
Title
Device Handling Characteristics
Description
Based on scale to evaluate device: Suturing, seal quality, strength, ease of use (Score from 1=easy to 5=difficult).
Time Frame
6 month follow-up
Title
Radiographic evaluation (Magnetic Resonance Imaging).
Description
To determine the presence or absence of the following measure: adhesion formation, new tissue formation, pseudomeningocele, extracerebal fluid collection and brain edema adjacent to device implant size Measurements will be done based on MRI imaging (X,Y,Z axis; in milimeters).
Time Frame
6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject between the ages of 18-75 Subject is scheduled for an elective cranial surgery with a dural damage that can be completely repaired/closed by a suture-able dural substitute (ArtiFascia device or other commercially available dural substitutes) Subject has undergone radiographic imaging (such as, MRI) in the past 6 months before enrolment Surgical wound is expected to be Class I/clean Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed Subject is able and willing to adhere to the required follow-up visits and testing Exclusion Criteria: Pregnant women or interest in becoming pregnant during the duration of the study Subject has known hydrocephalus Subject is unable to undergo MRI after the surgery Subject's life expectancy is less than 12 months Subject has a local or systemic infection (e.g. urinary tract infection (UTI), active pneumonia) or evidence of any surgical site infection, fever > 38.3℃, positive blood culture and/or a positive chest x-ray for acute infectious process Subject will require use of dural adhesive or sealant Subject is intended to undergo craniectomy wherein bone flap will not be returned Subject with suspected low success in wound healing due to past treatments (e.g. chemotherapy, radiation therapy, severe diabetes etc.) or other conditions (e.g. severe peripheral vascular disease, long standing steroids treatment) Subject has been clinically diagnosed with malignancy (other than basal cell carcinoma or low-grade glioma), uncontrolled diabetes (A1C>6.5%), sepsis, systemic collagen disease. Subject had chemotherapy and/or radiotherapy in the past 12 weeks before surgery or is planned to have chemotherapy or radiotherapy less than 12 weeks after surgery. Subject is an acute cranial trauma surgical case Subjects with a concurrent disease that would place the patient in excessive risk to the planned surgery Subject had a previous neurosurgery in the same anatomical site Subject with other undesirable symptoms defined by the principal investigator Patient has clinically significant coagulopathy as determined by the surgeon Subject is participating in another clinical trial using similar investigational devices/drugs
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
B-3600
Country
Belgium
Facility Name
St. Anne's University Hospital Brno
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Neurochirurgická klinika Přednosta FN Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Rabin Medical Center (Beilinson, Hasharon)
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Medical University of Gdańsk
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Barlicki University Hospital
City
Łódź
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario de Bellvitge
City
Barcelona
ZIP/Postal Code
09807
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair.

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