Post Market Study of Tutopatch In Craniotomy

RTI Surgical

Status: Invitation-only

Conditions: Craniotomy

Study type: Observational

Funder types: Industry

Identifiers

NCT07118020

RTI-2022-02

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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