Plastic SurgeryNCT04195854
STARS-R Registry: Retrospective Analysis of Poly-4-hydroxybutyrate (P4HB) Scaffold Use
An observational study of Plastic Surgery and Reconstructive Surgery, run by C. R. Bard at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plastic Surgery, Reconstructive Surgery
- What is being tested?
- P4HB product
- Type of treatment
- Medical device
- How many people
- 1,183 participants
- Where
- 10 sitesUnited States
- Study dates
- 17 Dec 2019to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Belcara Health
Baltimore, Maryland, 21209
Aesthetx
Campbell, California, 95008
Park Cities Surgery
Dallas, Texas, 75205
Southern Plastic Surgery
Duluth, Georgia, 30096
HKB Cosmetic Surgery
Huntersville, North Carolina, 28078
Meridian Plastic Surgery
Indianapolis, Indiana, 46290
Aesthetic Plastic Surgical Institute
Laguna Beach, California, 92651
Revalla Plastic Surgery and Medical Aesthetics
Littleton, Colorado, 80122
Sarasota Plastic Surgery
Sarasota, Florida, 34239
Politis Plastic Surgery
Tampa, Florida, 33607
About this study
Official title: STARS-R Registry: A Retrospective Observational Registry Evaluating the Use of P4HB Scaffolds for Soft Tissue Support in Plastic And Reconstructive Surgery
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.
Read the 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 inclusion/exclusion 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.
- Conditions
- Plastic Surgery, Reconstructive Surgery
- Being tested
- P4HB product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P4HB productDevice
Retrospective use of P4HB in various anatomies
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Anticipated 18 months
Secondary outcomes (1)
Surgeon/patient satisfaction
To evaluate surgeon/patient satisfaction with the P4HB scaffold
Measured: Anticipated 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start17 Dec 2019
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plastic SurgeryStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,183 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tepha, Inc.
- Responsible party
- Sponsor
- Investigators
- K Doyle, Study director, Tepha, Inc/Galatea Surgical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195854
- Sponsor's protocol ID
- CP-1060
- Status last verified
- Feb 2022
- First submitted
- 10 Dec 2019
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STARS-R Registry: A Retrospective Observational Registry Evaluating the Use of P4HB Scaffolds for Soft Tissue Support in Plastic And Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT04195854
- Acronym / sponsor ID
- CP-1060
- Conditions
- Plastic Surgery, Reconstructive Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,183 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Collaborators
- Tepha, Inc.
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 12 Dec 2019 (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 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 inclusion/exclusion 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P4HB productRetrospective use of P4HB in various anatomies | Device | – |
Primary outcome
Real-world utilization of P4HB scaffold
Time frame: Anticipated 18 months
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
1 secondary outcome
Surgeon/patient satisfaction
Time frame: Anticipated 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
K Doyle study director
Tepha, Inc/Galatea Surgical
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plastic Surgery and Reconstructive Surgery, run by C. R. Bard at 10 sites in United States.
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 1 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: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Real-world utilization of P4HB scaffold (time frame: Anticipated 18 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 4 Feb 2022.