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Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery (ENCASE-II)

Primary Purpose

Cerebrospinal Fluid Leak

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
LIQOSEAL
DuraSeal, Adherus
Sponsored by
Polyganics BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebrospinal Fluid Leak

Eligibility Criteria

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

Inclusion Criteria:

pre-operative

  1. Subjects who are able to provide written informed consent prior to participating in the clinical investigation.
  2. Subjects who are ≥ 18 years old.
  3. Subjects who are able to comply with the follow-up or other study requirements.
  4. Subjects wo are planned for elective surgery including a trepanation to reach the subdural infratentorial space (with lower limit of incision defined as the lower edge of C2) in whom a dural incision will be closed.
  5. Female subjects of child bearing potential must agree to use a form of contraception from the time of signing the informed consent form through 90 days post-surgery.

intra-operative

  1. Subjects with surgical wound classification Class I/Clean.
  2. Subjects with minimally 5 mm of dural space surrounding dural opening.

Exclusion Criteria:

pre-operative

  1. Female subjects who are pregnant or breastfeeding.
  2. Subjects with an assumed impaired coagulation due to medication or otherwise.
  3. Subjects suspected of an infection requiring antibiotics.
  4. Subjects with any type of dural diseases in planned dural closure area.
  5. Subjects requiring re-opening of planned surgical area within 90 days after surgery.
  6. Subjects with a known allergy to any of the components (Lactide-Caprolactone co-polyester; Butanediol-BDI co-polyurethane; Polyethylene glycol Succinimidyl Gluterate; Disodium hydrogen phosphate or D&C Green No 6) of LIQOSEAL®.
  7. Subjects who previously received a LIQOSEAL®.
  8. Subjects who previously participated in this study or any investigational drug or device study within 30 days of screening.
  9. Subjects with a presence of hydrocephalus.
  10. Subjects with contra-indication to MRI [cardiac pacemaker or defibrillator, severe claustrophobia, injured by a metallic object that was not removed, cochlear (ear) implants, metallic implants [e.g. knee replacement].

intra-operative

  1. Subjects in whom elevation of PEEP has a potential detrimental effect.
  2. Subjects who will require a CSF drain, electrodes or other devices passing the dural layer or extra to intracranial bypass surgery.
  3. Subjects who have primary closure of the dura mater with synthetic, nonautologous or autologous material other than galea.
  4. Subjects in whom no intra-operative CSF leakage is present after primary closure of the dura mater with elevation of PEEP.
  5. Subjects who after primary closure (including galea, if applicable) of the dura mater have a gap > 3 mm.
  6. Subjects whom dural opening size including 5 mm margin exceeds patch size (8 x 8 cm).

Sites / Locations

  • Stanford University
  • Baptist HealthRecruiting
  • Mayo Clinic
  • Mayo Clinic, Rochester
  • University of New MexicoRecruiting
  • Lenox Hill Hospital
  • University of CincinnattiRecruiting
  • OHSURecruiting
  • UT Southwestern Medical CenterRecruiting
  • University Hospitals of InnsbruckRecruiting
  • University Hospital GentRecruiting
  • Universitätsklinikum Düsseldorf
  • UMM
  • Molinette HospitalRecruiting
  • Elisabeth TweeSteden ZiekenhuisRecruiting
  • UMCURecruiting
  • University Hospital ZurichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Investigational arm

Control arm

Arm Description

Application of LIQOSEAL after closure of dura mater

Application of Adherus or DurSeal after closure of dura mater

Outcomes

Primary Outcome Measures

Composite endpoint defined as successful dural repair without any of the following compared to the control group: intra-operative CSF leakage percutaneous CSF leak significant pseudomeningocele wound infection

Secondary Outcome Measures

Full Information

First Posted
September 10, 2019
Last Updated
June 29, 2023
Sponsor
Polyganics BV
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1. Study Identification

Unique Protocol Identification Number
NCT04086550
Brief Title
Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
Acronym
ENCASE-II
Official Title
Randomized, Two-arm, Multicenter Study to Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polyganics BV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of the study is to clinically assess the safety and effectiveness of LIQOSEAL® as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure to show noninferiority compared to a control group.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational arm
Arm Type
Experimental
Arm Description
Application of LIQOSEAL after closure of dura mater
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
Application of Adherus or DurSeal after closure of dura mater
Intervention Type
Device
Intervention Name(s)
LIQOSEAL
Intervention Description
Adjunctive bioresorbable patch
Intervention Type
Device
Intervention Name(s)
DuraSeal, Adherus
Intervention Description
synthetic absorbable sealants
Primary Outcome Measure Information:
Title
Composite endpoint defined as successful dural repair without any of the following compared to the control group: intra-operative CSF leakage percutaneous CSF leak significant pseudomeningocele wound infection
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pre-operative Subjects who are able to provide written informed consent prior to participating in the clinical investigation. Subjects who are ≥ 18 years old. Subjects who are able to comply with the follow-up or other study requirements. Subjects wo are planned for elective surgery including a trepanation to reach the subdural infratentorial space (with lower limit of incision defined as the lower edge of C2) in whom a dural incision will be closed. Female subjects of child bearing potential must agree to use a form of contraception from the time of signing the informed consent form through 90 days post-surgery. intra-operative Subjects with surgical wound classification Class I/Clean. Subjects with minimally 5 mm of dural space surrounding dural opening. Exclusion Criteria: pre-operative Female subjects who are pregnant or breastfeeding. Subjects with an assumed impaired coagulation due to medication or otherwise. Subjects suspected of an infection requiring antibiotics. Subjects with any type of dural diseases in planned dural closure area. Subjects requiring re-opening of planned surgical area within 90 days after surgery. Subjects with a known allergy to any of the components (Lactide-Caprolactone co-polyester; Butanediol-BDI co-polyurethane; Polyethylene glycol Succinimidyl Gluterate; Disodium hydrogen phosphate or D&C Green No 6) of LIQOSEAL®. Subjects who previously received a LIQOSEAL®. Subjects who previously participated in this study or any investigational drug or device study within 30 days of screening. Subjects with a presence of hydrocephalus. Subjects with contra-indication to MRI [cardiac pacemaker or defibrillator, severe claustrophobia, injured by a metallic object that was not removed, cochlear (ear) implants, metallic implants [e.g. knee replacement]. intra-operative Subjects in whom elevation of PEEP has a potential detrimental effect. Subjects who will require a CSF drain, electrodes or other devices passing the dural layer or extra to intracranial bypass surgery. Subjects who have primary closure of the dura mater with synthetic, nonautologous or autologous material other than galea. Subjects in whom no intra-operative CSF leakage is present after primary closure of the dura mater with elevation of PEEP. Subjects who after primary closure (including galea, if applicable) of the dura mater have a gap > 3 mm. Subjects whom dural opening size including 5 mm margin exceeds patch size (8 x 8 cm).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Carlson
Phone
# 505 272 6094
Email
AndrewCarlson@salud.unm.edu
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M Lim
First Name & Middle Initial & Last Name & Degree
M Lim
Facility Name
Baptist Health
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A Dedashti
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
K Chaichana
Facility Name
Mayo Clinic, Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J Van Gompel
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Carlson
Email
AndrewCarlson@salud.unm.edu
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Langer
Facility Name
University of Cincinnatti
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M Zuccharello
Facility Name
OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J Cetas
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
K Abdullah
Facility Name
University Hospitals of Innsbruck
City
Innsbruck
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C Freyschlag
Facility Name
University Hospital Gent
City
Ghent
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
E Baert
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M Sabel
Facility Name
UMM
City
Mannheim
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A Abdulazim
Facility Name
Molinette Hospital
City
Torino
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
F Zenga
Facility Name
Elisabeth TweeSteden Ziekenhuis
City
Tilburg
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Depauw
Phone
013 221 00 00
Email
info@etz.nl
Facility Name
UMCU
City
Utrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
van Doormaal
Phone
088 755 5555
Email
info@umcutrecht.nl
Facility Name
University Hospital Zurich
City
Zürich
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Germans
Phone
44 255 11 11
Email
info@usz.ch

12. IPD Sharing Statement

Citations:
PubMed Identifier
35858894
Citation
Carlson AP, Slot EMH, van Doormaal TPC; ENCASE II study group; Voormolen EHJ, Dankbaar JW, Depauw P, Brouwers B, Germans MR, Baert E, Vandersteene J, Freyschlag CF, Freyschlag J, Thome C, Zenga F, Penner F, Abdulazim A, Sabel M, Rapp M, Beez T, Zuccarello M, Sauvageau E, Abdullah K, Welch B, Langer D, Ellis J, Dehdashti A, VanGompel J, Bendok B, Chaichana K, Liu J, Dogan A, Lim MK, Hayden MG. Evaluate the safety and efficacy of dura sealant patch in reducing cerebrospinal fluid leakage following elective cranial surgery (ENCASE II): study protocol for a randomized, two-arm, multicenter trial. Trials. 2022 Jul 20;23(1):581. doi: 10.1186/s13063-022-06490-8.
Results Reference
derived

Learn more about this trial

Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery

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