NCT04086550
Completed
Not Applicable
Randomized, Two-arm, Multicenter Study to Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
Polyganics BV17 sites in 7 countries228 target enrollmentStarted: May 20, 2021Last updated:
ConditionsCerebrospinal Fluid Leak
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Polyganics BV
- Enrollment
- 228
- Locations
- 17
- Primary Endpoint
- 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
Overview
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 intradural surgery with a dural closure procedure to show noninferiority compared to a control group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (17)
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