Post Market Study of Tutopatch In Craniotomy

A Prospective Post-Market Study of Tutopatch in Craniotomy

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07118020

Enrollment

Registered

2025-08-12

Start date

2025-09-21

Completion date

2027-12-31

Last updated

2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniotomy

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Device and/or Procedure Related Adverse Events	12 months

Secondary

Measure	Time frame
Rate of cerebrospinal fluid leakage	12 months
Incidence of re-operation	12 months

Countries

Austria, Spain

Outcome results