The trial is taking place at:
B

Baptist Health | Research Institute

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Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery (ENCASE-II)

P

Polyganics

Status

Enrolling

Conditions

Cerebrospinal Fluid Leak

Treatments

Device: DuraSeal, Adherus
Device: LIQOSEAL

Study type

Interventional

Funder types

Industry

Identifiers

NCT04086550
CIP-2

Details and patient eligibility

About

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.

Enrollment

228 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.
  • Subjects in whom no intra-operative CSF leakage is present after primary closure of the dura mater with elevation of PEEP.
  • Subjects who after primary closure (including galea, if applicable) of the dura mater have a gap > 3 mm.
  • Subjects whom dural opening size including 5 mm margin exceeds patch size (8 x 8 cm).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

228 participants in 2 patient groups

Investigational arm
Experimental group
Description:
Application of LIQOSEAL after closure of dura mater
Treatment:
Device: LIQOSEAL
Control arm
Active Comparator group
Description:
Application of Adherus or DurSeal after closure of dura mater
Treatment:
Device: DuraSeal, Adherus

Trial contacts and locations

17

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Central trial contact

Andrew Carlson

Data sourced from clinicaltrials.gov

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