By InvitationNot Applicable

Post Market Study of Tutopatch In Craniotomy

Austria, Spain75 participantsStarted 2025-09-21

Plain-language summary

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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Device and/or Procedure Related Adverse Events

Timeframe: 12 months

Trial details

NCT IDNCT07118020

SponsorRTI Surgical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-12

View on ClinicalTrials.gov More Craniotomy trials