Sealant Patch for Cerebrospinal Fluid Leak

(ENCASE-II Trial)

No longer recruiting at 19 trial locations

Overseen By Andrew Carlson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Polyganics BV

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Hydrocephalus, MRI contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new patch called LIQOSEAL® to determine its safety and effectiveness in reducing fluid leaks around the brain and spine after certain brain surgeries. Patients undergoing planned brain surgery with a specific type of incision may qualify. The study compares LIQOSEAL® to existing treatments like Adherus and DuraSeal (both dural sealants), focusing on their ability to prevent fluid leaks during and after surgery. As an unphased trial, this study allows patients to contribute to innovative research that could enhance surgical outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have impaired blood clotting due to medication, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LIQOSEAL® is likely safe for closing openings in the brain's protective covering during surgeries. Studies have found it can help reduce cerebrospinal fluid (CSF) leaks, which can cause complications after brain surgery. No serious safety issues have been reported with LIQOSEAL®, but further testing in clinical trials is needed to confirm its safety in humans.

In comparison, Adherus and DuraSeal are already used to seal the brain's outer layer after surgery. They are generally well-tolerated, with no major safety concerns reported. Both have a history of safety for patients undergoing similar procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about LIQOSEAL because it introduces a novel approach to managing cerebrospinal fluid leaks. Unlike traditional sealant options like Adherus and DuraSeal, LIQOSEAL employs a unique technology designed to enhance adhesion and reduce the risk of leaks after surgery. Its innovative design potentially offers improved durability and effectiveness, which could lead to better patient outcomes and greater reliability in preventing leaks. This advancement represents a promising step forward in neurosurgical care.

What evidence suggests that this trial's treatments could be effective for cerebrospinal fluid leak?

Research has shown that LIQOSEAL, which participants in this trial may receive, might help reduce leaks of the fluid around the brain during and after brain surgery. Some studies suggest that LIQOSEAL performs as well as other products like Adherus and DuraSeal, used in the control arm of this trial, in preventing these leaks. This is important because such leaks can lead to complications after surgery. LIQOSEAL creates a barrier over the surgery area, helping to keep the fluid in place. Early tests indicate that it does this safely and effectively, making LIQOSEAL a promising option for reducing fluid leaks in brain surgeries. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can consent and follow the study plan. Women must use birth control if they can have children. Participants need a clean surgical wound and at least 5mm of dural space around the opening. Excluded are those with certain dural diseases, MRI issues, high infection risk, recent other trials participation, large dural openings, LIQOSEAL® history or allergies to it.

Inclusion Criteria

Subjects who are able to provide written informed consent prior to participating in the clinical investigation

Subjects who are able to comply with the follow-up or other study requirements

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

Exclusion Criteria

You have any kind of disease in the area where the dura will be closed.

You cannot have an MRI for medical reasons.

You are at risk of being harmed by an increase in PEEP (positive end-expiratory pressure).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo elective cranial intradural surgery with application of either LIQOSEAL or control sealant to reduce CSF leakage

1 week

Post-operative Monitoring

Participants are monitored for intra- and post-operative CSF leakage to assess safety and effectiveness

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adherus
• DuraSeal
• LIQOSEAL

Trial Overview The trial tests LIQOSEAL®'s ability to prevent cerebrospinal fluid (CSF) leaks after brain surgery compared to DuraSeal and Adherus. It aims to show that LIQOSEAL® is not worse than the controls in stopping CSF leaks post-operation.

How Is the Trial Designed?

Group I: Investigational arm Experimental Treatment 1 Intervention

Application of LIQOSEAL after closure of dura mater

Group II: Control arm Active Control 1 Intervention

Application of Adherus or DurSeal after closure of dura mater

Who Is Running the Clinical Trial?

Polyganics BV

Lead Sponsor

Trials

6

Recruited

450+

Published Research Related to This Trial

DuraSeal® is a synthetic product used to help prevent cerebrospinal fluid (CSF) leakage after cranial and spinal surgeries, which can lead to complications like delayed healing and infections.

However, there is a risk associated with its use, as demonstrated by a case where a patient experienced cord compression due to the expansion of DuraSeal® following cervical spine surgery, highlighting the need for careful consideration in its application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Cervical Cord Compression Induced by Hydrogel Dural Sealant (DuraSeal®). Lee, SH., Park, CW., Lee, SG., et al.[2022]

Liqoseal, a new dural sealant patch, demonstrated significantly higher acute burst pressure compared to other sealants like Adherus, Duraseal, and Tachosil, indicating its superior ability to prevent cerebrospinal fluid leakage after surgery.

In both cranial and spinal models, Liqoseal maintained dural attachment under physiological conditions for up to 72 hours, showcasing its potential effectiveness in sealing dural defects during surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ex vivo evaluation of a multilayered sealant patch for watertight dural closure: cranial and spinal models. Kinaci, A., van Thoor, S., Redegeld, S., et al.[2022]

In a retrospective review of five cases of cerebrospinal fluid (CSF) leaks repaired with the DuraSeal Sealant System, four repairs were successful, indicating its efficacy in enhancing graft strength and forming a watertight seal during endoscopic skull-base surgery.

There were no complications associated with the use of DuraSeal, and its failure rate was comparable to that of Tisseel Fibrin Sealant, suggesting that DuraSeal is a safe and effective option for CSF leak repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of duraseal in repair of cerebrospinal fluid leaks. Chin, CJ., Kus, L., Rotenberg, BW.[2014]

Adherus dural sealant demonstrated a strong safety profile in endoscopic skull base surgery, with no reported postoperative cerebrospinal fluid leaks or other serious complications in a study of 26 patients, similar to a control group using DuraSeal.

Adherus was more easily identifiable on immediate postoperative MRI compared to DuraSeal (50% vs. 20.8%), while both sealants showed comparable quality of life outcomes as measured by SNOT-22 scores, suggesting Adherus is a viable alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherus Dural Sealant in Endoscopic Skull Base Surgery: Safety, Imaging Characteristics, and Sinonasal Quality of Life. Soneru, CP., Riley, CA., Minkowitz, S., et al.[2021]

DuraSeal, a dural sealant used to repair tiny durotomies during surgery, can expand significantly and potentially cause complications, such as nerve root compression, if not used cautiously.

In a case involving a 77-year-old woman, the use of DuraSeal after an intraoperative durotomy led to serious postoperative neurological issues, highlighting the need for careful monitoring of patients for signs of cauda equina syndrome following its application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cauda equina syndrome caused by the application of DuraSealTM in a microlaminectomy surgery: A case report. Yeh, KL., Wu, SH., Fuh, CS., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10227155/

Ex vivo and in vivo evaluation of transsphenoidal Liqoseal ... Predictive factors, 30-day clinical outcomes, and costs associated with cerebrospinal fluid leak in pituitary adenoma resection. J Neurol ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9297260/

Evaluate the safety and efficacy of dura sealant patch ... This trial will evaluate whether LIQOSEAL is non-inferior to control as a means of reducing CSF leakage and safety.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1878875019307405

Effectiveness of Sealants in Prevention of Cerebrospinal ... Currently available sealants seem not to reduce the rate of CSF leakage in spine surgery. In endoscopic and minimally invasive surgery, the CSF leakage rate is ...

4. thejns.org thejns.org/downloadpdf/view/journals/neurosurg-focus/58/2/article-pE11.pdf

focus - Journal of Neurosurgery Data extracted from each study included information about the study design, number of subjects, indication for dural repair and anatomical location of the ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/ame2.12294

Histological and magnetic resonance imaging assessment ... The aim of this study was to assess the safety of spinal Liqoseal application compared with cranial application using histology and magnetic resonance imaging ...

6. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06490-8

Evaluate the safety and efficacy of dura sealant patch in ... The objective of this study is to clinically assess the safety and effectiveness of LIQOSEAL as a means of reducing intra- as well as postoperative CSF leakage.

7. polyganics.com polyganics.com/wp-content/uploads/2020/07/One-pager-LIQOSEAL_HEA_FINAL.pdf

LIQOSEAL® reduces the risk of CSF leaks and healthcare ... Cerebrospinal fluid (CSF) leaks represent a significant patient burden, resulting in increased morbidity, prolonged hospital stays, possible surgical ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03566602

Evaluate the Safety and Performance of Dura Sealant ... The objective of the study is to clinically assess the safety and performance of the Dura Sealant Patch as a means of reducing intra- as well as post-operative ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8690992/

Safety and biodegradability of a synthetic dural sealant ... Liqoseal seems to be safe for intracranial use and is biodegradable. The safety and performance in humans needs to be further assessed in clinical trials.