Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery (ENCASE-II)
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ClinicalTrials.gov Identifier: NCT04086550 |
Recruitment Status :
Recruiting
First Posted : September 11, 2019
Last Update Posted : January 18, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cerebrospinal Fluid Leak | Device: LIQOSEAL Device: DuraSeal, Adherus | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 228 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 |
Actual Study Start Date : | May 20, 2021 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | March 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Investigational arm
Application of LIQOSEAL after closure of dura mater
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Device: LIQOSEAL
Adjunctive bioresorbable patch |
Active Comparator: Control arm
Application of Adherus or DurSeal after closure of dura mater
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Device: DuraSeal, Adherus
synthetic absorbable sealants |
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086550
Contact: Andrew Carlson | # 505 272 6094 | AndrewCarlson@salud.unm.edu |

Responsible Party: | Polyganics BV |
ClinicalTrials.gov Identifier: | NCT04086550 |
Other Study ID Numbers: |
CIP-2 |
First Posted: | September 11, 2019 Key Record Dates |
Last Update Posted: | January 18, 2022 |
Last Verified: | January 2022 |
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 |
Cerebrospinal Fluid Leak Neurologic Manifestations Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |