A Registry Study to Assess SYNTHECELTM Dura Repair
ConditionCraniotomy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDePuy Synthes Products, Inc.
About this trial
The purpose of this study is to assess how safe synthecel dura repair is and how well it performs in participants undergoing cranial surgery requiring dura repair (a procedure to close and protect the outer covering of the brain) in a regular, everyday healthcare environment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant or legally authorized representative who is willing to participate in the registry and provide written informed consent
Participant undergoing SYNTHECEL implantation for cranial dura repair on or after the start date of the registry study
Disqualifiers
None
Trial population
The study population includes participants undergoing cranial dura repair using SYNTHECEL Dura Repair.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
112 Participants
are grouped into 1 trial groupGroup A: SYNTHECEL Dura Repair
Trial outcomes
Primary outcomes
1
Demographics Characteristic Of Participants: Age
Participant's age at time of surgery will be reported.
Time frame
At baseline2
Demographics Characteristic Of Participants: Sex
Participant's sex will be reported.
Time frame
At baseline3
Demographics Characteristic Of Participants: Race
Participant's race will be reported.
Time frame
At baseline4
Demographics Characteristic Of Participants: Ethnicity
Participant's ethnicity will be reported.
Time frame
At baselineLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: