CraniSeal Post Approval Study

Conditions

• Leak, Cerebrospinal Fluid

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CraniSeal — DEVICE
  CraniSeal is a PEG Dural Sealant
• DuraSeal — DEVICE
  DuraSeal is a PEG Dural Sealant

Study Details

To collect post-approval data comparing the safety and effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant. The study has been powered specifically to determine whether the CraniSeal device when used as an adjunct to sutured dural closure following elective cranial surgery is no worse than (i.e., non-inferior) to the DuraSeal device with respect to proportion of subjects free from post-operative cerebrospinal fluid (CSF) leaks. Additional safety outcomes (i.e., surgical site infections and adverse events/device-related adverse events) will also be captured and compared.

Key Dates

Start date

May 29, 2024

Status verified

Feb 2026

Primary completion

Feb 28, 2027

Completion

Feb 28, 2027

Study Design

Enrollment

224 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CraniSeal
  CraniSeal
• Active Comparator: DuraSeal
  DuraSeal

Primary Outcome Measure

Absence of CSF Leaks [ Time Frame: 90 days ]

Central Contacts

• M Pace
  6172335873
  [email protected]

Locations (8)

Find similar trials in Los Angeles, CA