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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04195854
Other study ID # CP-1060
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 17, 2019
Est. completion date January 31, 2022

Study information

Verified date February 2022
Source C. R. Bard
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1183
Est. completion date January 31, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Device:
P4HB product
Retrospective use of P4HB in various anatomies

Locations

Country Name City State
United States Belcara Health Baltimore Maryland
United States Aesthetx Campbell California
United States Park Cities Surgery Dallas Texas
United States Southern Plastic Surgery Duluth Georgia
United States HKB Cosmetic Surgery Huntersville North Carolina
United States Meridian Plastic Surgery Indianapolis Indiana
United States Aesthetic Plastic Surgical Institute Laguna Beach California
United States Revalla Plastic Surgery and Medical Aesthetics Littleton Colorado
United States Sarasota Plastic Surgery Sarasota Florida
United States Politis Plastic Surgery Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
C. R. Bard Tepha, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other Safety - adverse and serious adverse events 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
Other Follow up visits Assessment of healing, menopausal status, Weight, BMI Anticipated 18 months
Primary 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 Surgeon/patient satisfaction To evaluate surgeon/patient satisfaction with the P4HB scaffold Anticipated 18 months
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