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

NCT04086550 | Completed DMC FDA Device

• 1 other identifier: CIP-2
• Study Type: interventional
• Target: 228
• Locations: 7 countries
• Sites: 17

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.

Conditions

Cerebrospinal Fluid Leak

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Investigational arm

EXPERIMENTAL

Application of LIQOSEAL after closure of dura mater

Device: LIQOSEAL

Control arm

ACTIVE COMPARATOR

Application of Adherus or DurSeal after closure of dura mater

Device: DuraSeal, Adherus

Interventions

LIQOSEAL DEVICE

Adjunctive bioresorbable patch

Investigational arm

DuraSeal, Adherus DEVICE

synthetic absorbable sealants

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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
• Subjects in whom elevation of PEEP has a potential detrimental effect.
• Subjects who will require a CSF drain, electrodes or other devices passing the dural layer or extra to intracranial bypass surgery.
• Subjects who have primary closure of the dura mater with synthetic, nonautologous or autologous material other than galea.

Sponsors & Collaborators

• Polyganics BV: lead

Study Sites (17)

Stanford University

Palo Alto, California, 94305, United States

Location

Baptist Health

Jacksonville, Florida, 32207, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic, Rochester

Rochester, Minnesota, 55905, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

University of Cincinnatti

Cincinnati, Ohio, 45229, United States

Location

OHSU

Portland, Oregon, 97239, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University Hospitals of Innsbruck

Innsbruck, Austria

Location

University Hospital Gent

Ghent, Belgium

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

UMM

Mannheim, Germany

Location

Molinette Hospital

Torino, Italy

Location

Elisabeth TweeSteden Ziekenhuis

Tilburg, Netherlands

Location

UMCU

Utrecht, Netherlands

Location

University Hospital Zurich

Zurich, Switzerland

Location

Related Publications (1)

• Carlson AP, Slot EMH, van Doormaal TPC; ENCASE II study group; Voormolen EHJ, Dankbaar JW, Depauw P, Brouwers B, Germans MR, Baert E, Vandersteene J, Freyschlag CF, Freyschlag J, Thome C, Zenga F, Penner F, Abdulazim A, Sabel M, Rapp M, Beez T, Zuccarello M, Sauvageau E, Abdullah K, Welch B, Langer D, Ellis J, Dehdashti A, VanGompel J, Bendok B, Chaichana K, Liu J, Dogan A, Lim MK, Hayden MG. Evaluate the safety and efficacy of dura sealant patch in reducing cerebrospinal fluid leakage following elective cranial surgery (ENCASE II): study protocol for a randomized, two-arm, multicenter trial. Trials. 2022 Jul 20;23(1):581. doi: 10.1186/s13063-022-06490-8.

  PMID: 35858894 DERIVED

MeSH Terms

Conditions

Cerebrospinal Fluid Leak

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 11, 2019
• Study Start: May 20, 2021
• Primary Completion: February 13, 2024
• Study Completion: February 13, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

CH (1); AU (1); US (9); BE (1); DE (2); NL (2); IT (1)