Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery

Cerebrospinal Fluid Leak Clinical Trial

— ENCASE-II  

Official title:

Randomized, Two-arm, Multicenter Study to Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04086550
• Other study ID #: CIP-2
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: January 2024

Study information

• Verified date: June 2023
• Source: Polyganics BV
• Contact: Andrew Carlson
• Phone: # 505 272 6094
• Email: AndrewCarlson[@]salud.unm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: January 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

pre-operative

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

2. Subjects who are = 18 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 contraception from the time of signing the informed consent form through 90 days post-surgery.

intra-operative

1. Subjects with surgical wound classification Class I/Clean.

2. Subjects with minimally 5 mm of dural space surrounding dural opening.

Exclusion Criteria:

pre-operative

1. Female subjects who are pregnant or breastfeeding.

2. Subjects with an assumed impaired coagulation due to medication or otherwise.

3. Subjects suspected of an infection requiring antibiotics.

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 surgery.

6. 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®.

7. Subjects who previously received a LIQOSEAL®.

8. Subjects who previously participated in this study or any investigational drug or device study within 30 days of screening.

9. Subjects with a presence of hydrocephalus.

10. Subjects with contra-indication to MRI [cardiac pacemaker or defibrillator, severe claustrophobia, injured by a metallic object that was not removed, cochlear (ear) implants, metallic implants [e.g. knee replacement].

intra-operative

1. Subjects in whom elevation of PEEP has a potential detrimental effect.

2. Subjects who will require a CSF drain, electrodes or other devices passing the dural layer or extra to intracranial bypass surgery.

3. Subjects who have primary closure of the dura mater with synthetic, nonautologous or autologous material other than galea.

4. Subjects in whom no intra-operative CSF leakage is present after primary closure of the dura mater with elevation of PEEP.

5. Subjects who after primary closure (including galea, if applicable) of the dura mater have a gap > 3 mm.

6. Subjects whom dural opening size including 5 mm margin exceeds patch size (8 x 8 cm).

Related Conditions & MeSH terms

• Cerebrospinal Fluid Leak

Intervention

Device:
• LIQOSEAL
Adjunctive bioresorbable patch
• DuraSeal, Adherus
synthetic absorbable sealants

Locations

Country	Name	City	State
Austria	University Hospitals of Innsbruck	Innsbruck
Belgium	University Hospital Gent	Ghent
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	UMM	Mannheim
Italy	Molinette Hospital	Torino
Netherlands	Elisabeth TweeSteden Ziekenhuis	Tilburg
Netherlands	UMCU	Utrecht
Switzerland	University Hospital Zurich	Zürich
United States	University of New Mexico	Albuquerque	New Mexico
United States	University of Cincinnatti	Cincinnati	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Baptist Health	Jacksonville	Florida
United States	Mayo Clinic	Jacksonville	Florida
United States	Lenox Hill Hospital	New York	New York
United States	Stanford University	Palo Alto	California
United States	OHSU	Portland	Oregon
United States	Mayo Clinic, Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Polyganics BV

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Germany,  Italy,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		30 days