Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective… (NCT04086550) | Clinical Trial Compass
CompletedNot Applicable
Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
United States228 participantsStarted 2021-05-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Subjects with surgical wound classification Class I/Clean.
✓. Subjects with minimally 5 mm of dural space surrounding dural opening.
Exclusion criteria
✕. 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.
What they're measuring
1
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
✕. 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.