NL-OMON52748
Completed
N/A
Randomized, two-arm, multicenter study to evaluate the safety and efficacy of Dura Sealant Patch in reducing CSF leakage following elective cranial surgery - ENCASE II
Polyganics BV, Groningen0 sites26 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Polyganics BV, Groningen
- Enrollment
- 26
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •Preoperative
- •1\. Subjects who are able to provide written informed consent prior to
- •participating in the clinical investigation.
- •2\. Subjects who are \>\= 22 years old.
- •3\. Subjects who are able to comply with the follow\-up or other study
- •requirements.
- •4\. 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.
- •5\. Female subjects of child bearing potential must agree to use a form of
Exclusion Criteria
- •Preoperative
- •1\. Female subjects who are pregnant or breastfeeding.
- •2\. Subjects with an assumed impaired coagulation due to medication or otherwise.
- •3\. Subjects with presence of an infection.
- •4\. Subjects with any type of dural diseases in planned dural closure area.
- •5\. Subjects requiring re\-opening of planned surgical area within 90 days after
- •6\. Subjects with a known allergy to any of the components of LIQOSEAL®
- •(Lactide\-Caprolactone co\-polyester; Butanediol\-BDI co\-polyurethane;
- •Polyethylene glycol Succinimidyl Gluterate; Disodium hydrogen phosphate or D\&C
- •Green No 6\), DuraSeal and Adherus.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 4
A randomized, multicentre, double-blind, parallel, sham-controlled study of the gammaCore®, a non-invasive neurostimulator device for the acute relief of episodic and chronic cluster headache.cluster headaches10019231NL-OMON40599electroCore LLC35
Completed
Phase 4
A Prospective, Randomized, Multi-center Study to Assess the SaFety of the Orsiro Mission Stent compared to the ResoLute Onyx Stent in Subjects at High Risk for Bleeding in combination With 1-month Dual Antiplatelet Therapy (DAPT).NL-OMON52323BIOTRONIK AG1
Completed
Phase 3
A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS)ALSAmyotrophic Lateral Sclerosis10011305NL-OMON44970AB Science10
Completed
N/A
Single-arm, open-label, multicenter study to evaluate the safety and performance of Dura Sealant Patch in reducing CSF leakage following elective cranial surgeryNL-OMON48601Polyganics BV, Groningen31
Completed
Phase 2
A randomized, double-blind, parallel group study to evaluate metabolic effects of LCZ696 and amlodipine in obese hypertensive subjects: the CLCZ696B2207 studyInsulin sensitivitymetabolism1001842410013317NL-OMON40044Medisch Universitair Ziekenhuis Maastricht28