Post Market Study of Tutopatch In Craniotomy

NCT ID: NCT07118020

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-21

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Craniotomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

RTI Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitatsklinik fur Neurochirurgie der PMU

Salzburg, , Austria

Site Status

Hospital Universitari Vali d'Hebron

Barcelona, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RTI-2022-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.