Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02457546




Registration number
NCT02457546
Ethics application status
Date submitted
27/05/2015
Date registered
29/05/2015
Date last updated
10/01/2019

Titles & IDs
Public title
The EVICEL® Neurosurgery Phase III Study
Scientific title
A Single-Blinded, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® Fibrin Sealant (Human) Compared to a Hydrogel Sealant as an Adjunct to Sutured Dural Repair
Secondary ID [1] 0 0
2014-003954-15
Secondary ID [2] 0 0
BIOS-14-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebrospinal Fluid Leak 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: EVICEL Fibrin Sealant - EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen

Active comparator: Hydrogel sealant - The sealant is composed of two solutions, a polyethylene glycol (PEG) ester solution and a trilysine amine solution
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Effectiveness Endpoint Success Number of Successes (Subjects That Had no Inter-operative CSF Leak Following Valsalva Maneuver and no CSF Leak or Pseudomeningocele in the Surgical Area During the 30-day Follow-up Period)
Timepoint [1] 0 0
Intraoperatively through 30-day follow-up

Eligibility
Key inclusion criteria
* Subjects =18 years of age undergoing craniotomy/craniectomy for pathological processes in the supratentorial region or posterior fossa
* Subjects or legally authorized representatives must be willing to participate in the study and provide written informed consent.
* Surgical wound classification Class I
* The cuff of native dura along the craniotomy edge on each side is adequate, based on surgeon's judgment, to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product
* Presence of intra-operative cerebrospinal fluid (CSF) leakage following primary dural closure or after Valsalva maneuver
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with a dural lesion from a recent surgery that still has the potential for CSF leakage.
* Chemotherapy within 30-days prior to enrollment or scheduled within 7-days following surgery
* Radiation therapy to the head within 30-days prior to enrollment or scheduled within 7-days following surgery
* A previous craniotomy/craniectomy within 6 months prior to the study surgery.
* Known hypersensitivity to the components of the investigational product.
* Subjects with a known allergy to FD&C Blue #1 dye
* Subjects with an infection present at the surgical site
* Subjects with an infection indicated by any one of the following: clinical diagnosis of infection, fever, positive urine culture, positive blood culture, positive chest X-ray.
* Female subjects of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period.
* Female subjects who are nursing.
* Exposure to another investigational drug or device clinical trial within 30 days prior to enrollment or anticipated in the 60 day follow-up period.
* Subjects with severely altered renal or hepatic function, with a compromised immune system or autoimmune disease who can NOT receive hydrogel sealant.
* Subjects with penetratring traumatic injuries to the head with damage to the dura
* Dural injury during craniotomy/craniectomy that cannot be eliminated by widening the craniotomy/craniectomy to recreate the native dural cuff.
* Patient has a gap between durotomy edges of greater than 2mm after primary dural closure.
* Approaches that would not allow sutured dural closure such as trans-sphenoidal or trans-labirinthine-/petrosal/-mastoid. Superficial penetration of mastoid air cells are allowed.
* Use of implants made of synthetic materials coming into direct contact with dura
* Use of other fibrin sealants or PEG-based sealants on the dural closure. Approved fibrin sealants may be used for hemostasis if not in contact with the dura.
* Hydrocephalus, except occlusive hydrocephalus caused by posterior fossa pathology or incompletely open cerebrospinal fluid pathways, to be treated during surgical procedure.
* Placement of Gliadel Wafers
* Intersecting durotomy scars in the surgical path from a previous operation that cannot be completely removed by the planned dural resection.
* Two or more separate cranial dural defects, including defects from ventricular cannulation and ventriculo-peritoneal shunting.
* Subjects with any other intra-operative findings identified by the surgeon that may preclude the conduct of the study procedure.
* Confined bony structures where nerves are present where neural compression may result due to swelling.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/10/2017
Sample size
Target
Accrual to date
Final
234
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Clinical Investigation Site #51 - Sydney
Recruitment hospital [2] 0 0
Clinical Investigation Site #54 - Adelaide
Recruitment hospital [3] 0 0
Clinical Investigation Site #50 - Melbourne
Recruitment hospital [4] 0 0
Clinical Investigation Site #52 - Richmond
Recruitment postcode(s) [1] 0 0
2109 - Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
Belgium
State/province [12] 0 0
Genk
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland
Country [16] 0 0
United Kingdom
State/province [16] 0 0
England

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ethicon, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard Kocharian, MD, PhD
Address 0 0
Ethicon, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02457546