Post Market Study of Tutopatch In Craniotomy

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.

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Key information

Conditions

Craniotomy

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitatsklinik fur Neurochirurgie der PMU, Salzburg, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

RTI Surgical

Industry

Registry information

Official study title

A Prospective Post-Market Study of Tutopatch in Craniotomy

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Aug 12, 2025
Registry last updated: Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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