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Sealant Patch
Sealant Patch for Cerebrospinal Fluid Leak (ENCASE-II Trial)
N/A
Recruiting
Research Sponsored by Polyganics BV
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
ENCASE-II Trial Summary
This trial is testing whether a new sealant is as effective as the current standard in reducing cerebrospinal fluid leakage after cranial surgery.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include allergic reactions to patch components, complications from improper sealing leading to CSF leakage which could result in headaches or infections.
ENCASE-II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
ENCASE-II Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Investigational armExperimental Treatment1 Intervention
Application of LIQOSEAL after closure of dura mater
Group II: Control armActive Control1 Intervention
Application of Adherus or DurSeal after closure of dura mater
Find a Location
Who is running the clinical trial?
Polyganics BVLead Sponsor
4 Previous Clinical Trials
203 Total Patients Enrolled
1 Trials studying Cerebrospinal Fluid Leak
40 Patients Enrolled for Cerebrospinal Fluid Leak
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have any kind of disease in the area where the dura will be closed.You are 18 years old or older.You cannot have an MRI for medical reasons.You are at risk of being harmed by an increase in PEEP (positive end-expiratory pressure).You are suspected to have an infection that needs antibiotics.You need to have another surgery in the same area within 90 days.The size of the opening in the protective covering of the brain is larger than the size of the patch that can be used to cover it.People who have used LIQOSEAL® before.You will need surgery that involves placing devices or draining fluid from inside your brain.You have had a type of surgery where a specific material was used to close the covering of the brain, called the dura mater.You have a gap in the protective layer around your brain that is larger than 3 mm after it has been closed.You need to have at least 5 mm of space around the dural opening in your body.You have an allergy to any parts of LIQOSEAL®.You don't have any leaking of cerebrospinal fluid after surgery and your PEEP is normal.You have a condition that affects your blood's ability to clot due to medication or other reasons.You have hydrocephalus.
Research Study Groups:
This trial has the following groups:- Group 1: Control arm
- Group 2: Investigational arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum capacity of enrollees for this trial?
"To fulfill the necessary requirements of this medical trial, 228 qualified individuals need to participate. These participants can join from multiple locations including Rochester, Minnesota and Cincinnati, Ohio's Mayo Clinic sites."
Answered by AI
What is the extent of this clinical trial's presence?
"11 medical sites are participating in this study, with notable locations such as Mayo Clinic Rochester (Rochester), Mayo Clinic Cincinnati, and University of Cincinnatti Albuquerque. Other facilities across the United States are also hosting trials for this medication."
Answered by AI
Are applications for this experiment currently being accepted?
"According to the clinicaltrials.gov site, this medical trial is in a state of active recruitment and was initially published on May 20th 2021 with its most recent amendment taking place on January 14th 2022."
Answered by AI
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