Cerebrospinal Fluid LeakENCASE-IINCT04086550
Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
A study testing LIQOSEAL and DuraSeal, Adherus in people with Cerebrospinal Fluid Leak, run by Polyganics BV at 17 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrospinal Fluid Leak
- What is being tested?
- LIQOSEAL and DuraSeal, Adherus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 17 sitesin 7 countries
- Study dates
- 20 May 2021to 13 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- intra-operative
- Subjects with surgical wound classification Class I/Clean.
- Subjects with minimally 5 mm of dural space surrounding dural opening.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
17 sites in 7 countries.
17 sites in 7 countries
United States9 sites
University of New Mexico
Albuquerque, New Mexico, 87131
University of Cincinnatti
Cincinnati, Ohio, 45229
UT Southwestern Medical Center
Dallas, Texas, 75390
Baptist Health
Jacksonville, Florida, 32207
Mayo Clinic
Jacksonville, Florida, 32224
Lenox Hill Hospital
New York, New York, 10075
Stanford University
Palo Alto, California, 94305
OHSU
Portland, Oregon, 97239
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
About this study
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
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.
- Conditions
- Cerebrospinal Fluid Leak
- Being tested
- LIQOSEAL, DuraSeal, Adherus
- Medical subject headings
- Cerebrospinal Fluid Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIQOSEALDevice
Adjunctive bioresorbable patch
DuraSeal, AdherusDevice
synthetic absorbable sealants
| Study group | Role | What they receive |
|---|---|---|
| Investigational arm | Experimental | Application of LIQOSEAL after closure of dura mater Receives: Device: LIQOSEAL |
| Control arm | Active comparator | Application of Adherus or DurSeal after closure of dura mater Receives: Device: DuraSeal, Adherus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start20 May 2021
- Primary completion13 Feb 2024
- Study completion13 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrospinal Fluid LeakStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polyganics BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086550
- Sponsor's protocol ID
- CIP-2
- Acronym
- ENCASE-II
- Status last verified
- Jun 2024
- First submitted
- 10 Sep 2019
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 35858894
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04086550
- Acronym / sponsor ID
- ENCASE-II / CIP-2
- Conditions
- Cerebrospinal Fluid Leak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Polyganics BVIndustry (pharma, biotech, devices)
- Study start
- 20 May 2021 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational arm | Experimental | Device: LIQOSEALApplication of LIQOSEAL after closure of dura mater |
| Control arm | Active comparator | Device: DuraSeal, AdherusApplication of Adherus or DurSeal after closure of dura mater |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIQOSEALAdjunctive bioresorbable patch | Device | Investigational arm |
| DuraSeal, Adherussynthetic absorbable sealants | Device | Control arm |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Derived from this study: PubMed 35858894Carlson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIQOSEAL and DuraSeal, Adherus in people with Cerebrospinal Fluid Leak, run by Polyganics BV at 17 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Germany, Netherlands, Austria, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04086550, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.