Status:
COMPLETED
Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
Lead Sponsor:
Polyganics BV
Conditions:
Cerebrospinal Fluid Leak
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2024
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT04086550
Start Date
May 20 2021
End Date
February 13 2024
Last Update
June 26 2024
Active Locations (17)
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1
Stanford University
Palo Alto, California, United States, 94305
2
Baptist Health
Jacksonville, Florida, United States, 32207
3
Mayo Clinic
Jacksonville, Florida, United States, 32224
4
Mayo Clinic, Rochester
Rochester, Minnesota, United States, 55905