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

Completed · Not applicable

Conditions studied: Cerebrospinal Fluid Leak

In brief

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.

Key facts

Study ID

NCT04086550

Run by

Polyganics BV

People needed

228

Starts

2021-05-20

Expected to finish

2024-02-13

Last updated by the study team

2024-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Stanford University — Palo Alto, California, United States
• Baptist Health — Jacksonville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Mayo Clinic, Rochester — Rochester, Minnesota, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Lenox Hill Hospital — New York, New York, United States
• University of Cincinnatti — Cincinnati, Ohio, United States
• OHSU — Portland, Oregon, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• University Hospitals of Innsbruck — Innsbruck, Austria
• University Hospital Gent — Ghent, Belgium
• Universitätsklinikum Düsseldorf — Düsseldorf, Germany
• UMM — Mannheim, Germany
• Molinette Hospital — Torino, Italy
• Elisabeth TweeSteden Ziekenhuis — Tilburg, Netherlands
• UMCU — Utrecht, Netherlands
• University Hospital Zurich — Zurich, Switzerland

Full record on ClinicalTrials.gov

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