Post Market Study of Tutopatch In Craniotomy

N/AEnrolling By InvitationNCT07118020

RTI Surgical75 enrolled

Overview

This is a post market prospective, multi-center study of up to 75 participants at approximately 8 clinical study sites. The objective of the study is to evaluate safety by assessing incidence of device and/or procedure related adverse events.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Craniotomy

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Males and females of any age undergoing craniotomy * Able to return for scheduled study visits * Informed consent is able to be obtained Exclusion Criteria: * Life expectancy \< 12 months * Local cerebral infection * Previous surgery at same anatomical site * Currently enrolled in another study that would affect validity of study * Known hypersensitivity to bovine collagen

Locations (2)

Universitatsklinik fur Neurochirurgie der PMU

Salzburg, Austria

Hospital Universitari Vali d'Hebron

Barcelona, Spain

Outcomes

Primary Outcomes

Device and/or Procedure Related Adverse Events

Time frame: 12 months

Secondary Outcomes

Rate of cerebrospinal fluid leakage

Time frame: 12 months

Incidence of re-operation

Time frame: 12 months

Data from ClinicalTrials.gov

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