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Clinical Trials in Spain / NCT07118020
Enrolling by invitation Observational

Post Market Study of Tutopatch In Craniotomy

NCT07118020 · tracked via the Priya Life Science Spain tracker
Sponsor
RTI Surgical
Phase
Observational
Started
2025-09-21
Last updated
2025-11-25

Condition(s) studied

Craniotomy

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Device and/or Procedure Related Adverse Events — 12 months

Trial sites (2)

FacilityCityRegionStatus
Universitatsklinik fur Neurochirurgie der PMU Salzburg Austria
Hospital Universitari Vali d'Hebron Barcelona Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07118020 on ClinicalTrials.gov ↗ ← All trials in Spain