Ignite Creation Date:
2024-05-06 @ 2:01 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04195854
Status:
COMPLETED
Last Update Posted:
2022-02-04
First Post:
2019-12-10
Brief Title:
STARS-R Registry Retrospective Analysis of Poly-4-hydroxybutyrate P4HB Scaffold Use
Sponsor:
C R Bard
Organization:
C R Bard
Study Overview
Official Title:
STARS-R Registry A Retrospective Observational Registry Evaluating the Use of P4HB Scaffolds for Soft Tissue Support in Plastic And Reconstructive Surgery
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a retrospective chart review performed at multiple clinics aimed at providing real-world evidence of the use and safety of the P4HB scaffold Data on patient demographics relevant medical history product and procedure used product safety and outcome measures will be collected as available
Detailed Description:
This is a retrospective chart review performed at multiple clinics aimed at providing real-world evidence of the use and safety of P4HB products Adults greater than or equal to 18 years old who have undergone a plastic or reconstructive surgical procedure with P4HB on or after January 1 2014 will be identified using the centers medical records Data on patient demographics relevant medical history product and procedure used product safety and subjective and objective outcome measures will be collected The data may be used in publication and education and may inform future product development including future clinical trials The trial will include all consecutive participants who meet inclusionexclusion criteria with the goal of having up to 5000 participants A screening log will be kept at the site of all participants screened regardless of whether or not they were included in the analysis Participants will be entered into the database based on the consecutive group meeting enrollment criteria
The overall purpose of this study is to gain an understanding of the use and safety of treatments on a historic collection basis Hypothesis testing is not necessary for the statistical analyses of the generated data Broad inclusion criteria with few exclusion criteria are utilized so as to avoid censoring historic real-world use of the device
The overall purpose of this study is to gain an understanding of the use and safety of treatments on a historic collection basis Hypothesis testing is not necessary for the statistical analyses of the generated data Broad inclusion criteria with few exclusion criteria are utilized so as to avoid censoring historic real-world use of the device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None