STARS-R Registry: Retrospective Analysis of Poly-4-hydroxybutyrate (P4HB) Scaffold Use
STARS-R Registry: A Retrospective Observational Registry Evaluating the Use of P4HB Scaffolds for Soft Tissue Support in Plastic And Reconstructive Surgery
1 other identifier
observational
1,183
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2019
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2019
CompletedFirst Posted
Study publicly available on registry
December 12, 2019
CompletedStudy Start
First participant enrolled
December 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedFebruary 4, 2022
February 1, 2022
2.1 years
December 10, 2019
February 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Real-world utilization of P4HB scaffold
To obtain data from real-world utilization of P4HB scaffolds in order to evaluate how and why these products are being used and to assess the safety of these products
Anticipated 18 months
Secondary Outcomes (1)
Surgeon/patient satisfaction
Anticipated 18 months
Other Outcomes (3)
Use of Product
Anticipated 18 months
Safety - adverse and serious adverse events
Anticipated 18 months
Follow up visits
Anticipated 18 months
Interventions
Retrospective use of P4HB in various anatomies
Eligibility Criteria
Patients greater than or equal to 18 years of age who underwent plastic or reconstructive surgical procedure with P4HB on or after January 1, 2014 until the date of site initiated data collection and who have at least 1 visit of documented post-procedure follow-up
You may qualify if:
- Age greater than or equal to 18 years old
- Underwent plastic or reconstructive surgical procedure with P4HB on or after January 1, 2014 until the date of site initiated data collection
- At least 1 visit of documented post-procedure follow-up
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- C. R. Bardlead
- Tepha, Inc.collaborator
Study Sites (10)
Aesthetx
Campbell, California, 95008, United States
Aesthetic Plastic Surgical Institute
Laguna Beach, California, 92651, United States
Revalla Plastic Surgery and Medical Aesthetics
Littleton, Colorado, 80122, United States
Sarasota Plastic Surgery
Sarasota, Florida, 34239, United States
Politis Plastic Surgery
Tampa, Florida, 33607, United States
Southern Plastic Surgery
Duluth, Georgia, 30096, United States
Meridian Plastic Surgery
Indianapolis, Indiana, 46290, United States
Belcara Health
Baltimore, Maryland, 21209, United States
HKB Cosmetic Surgery
Huntersville, North Carolina, 28078, United States
Park Cities Surgery
Dallas, Texas, 75205, United States
Study Officials
- STUDY DIRECTOR
K Doyle
Tepha, Inc/Galatea Surgical
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2019
First Posted
December 12, 2019
Study Start
December 17, 2019
Primary Completion
January 31, 2022
Study Completion
January 31, 2022
Last Updated
February 4, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share