CraniotomyNCT07118020
Post Market Study of Tutopatch In Craniotomy
An observational study of Craniotomy, run by RTI Surgical at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Craniotomy
- How many people
- 75 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Sep 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants in this study will be candidates for craniotomy due to tumor, aneurysm, trauma or other medical conditions recruited from the participating investigator's population
Who may be able to join
- Males and females of any age undergoing craniotomy
- Able to return for scheduled study visits
- Informed consent is able to be obtained
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
About this study
Official title: A Prospective 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.
- Conditions
- Craniotomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Device and/or Procedure Related Adverse Events
Measured: 12 months
Secondary outcomes (2)
Rate of cerebrospinal fluid leakage
Measured: 12 months
Incidence of re-operation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start21 Sep 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTI Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118020
- Sponsor's protocol ID
- RTI-2022-02
- Status last verified
- Nov 2025
- First submitted
- 5 Aug 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Post-Market Study of Tutopatch in Craniotomy
- ClinicalTrials.gov ID
- NCT07118020
- Acronym / sponsor ID
- RTI-2022-02
- Conditions
- Craniotomy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- RTI SurgicalIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants in this study will be candidates for craniotomy due to tumor, aneurysm, trauma or other medical conditions recruited from the participating investigator's population
Key inclusion criteria (3 listed)
- Males and females of any age undergoing craniotomy
- Able to return for scheduled study visits
- Informed consent is able to be obtained
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Device and/or Procedure Related Adverse Events
Time frame: 12 months
2 secondary outcomes
Rate of cerebrospinal fluid leakage
Time frame: 12 months
Incidence of re-operation
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniotomy, run by RTI Surgical at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device and/or Procedure Related Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.