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| Name | Class |
|---|---|
| Tepha, Inc. | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P4HB product | Device | Retrospective use of P4HB in various anatomies |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon/patient satisfaction | To evaluate surgeon/patient satisfaction with the P4HB scaffold | Anticipated 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Use of Product | Type of procedure, reason for procedure, surgical approach tissue assessment, use of other medical devices, concomitant procedures, use of fat grafting | Anticipated 18 months |
| Safety - adverse and serious adverse events |
Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| K Doyle | Tepha, Inc/Galatea Surgical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aesthetx | Campbell | California | 95008 | United States | ||
| Aesthetic Plastic Surgical Institute |
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Adverse events and serious adverse events related to the study device or procedure, or occurring at procedure anatomy. Medications used in treatment of adverse events
| Anticipated 18 months |
| Follow up visits | Assessment of healing, menopausal status, Weight, BMI | Anticipated 18 months |
| 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 |