Reconstructive Surgical Procedures Clinical Trial
— PRSOfficial title:
A Retrospective Assessment of OviTex PRS (OviTex) Permanent and Resorbable Devices in Subjects Who Have Previously Undergone a Breast Reconstruction
Verified date | November 2023 |
Source | Tela Bio Inc |
Contact | Zachary Sterner |
Phone | 937-514-2262 |
zsterner[@]telabio.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The objective of this retrospective-prospective, observational study is to evaluate the safety profile overall and within two device types of OviTex PRS in previous pre-pectoral or sub-pectoral implant-based breast reconstructions.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | March 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Patient was between 18 years and 70 years of age (inclusive) at the time of surgery. 2. At the time of surgery, the patient received an OviTex PRS Permanent (R20143 or R20243) or Resorbable (R20152 or R20252) implant in conjunction with an implant-based breast reconstruction. 3. Patient is 6-months or more post initial surgical procedure. Exclusion Criteria: 1. Patient received a textured expander or implant. 2. Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding their index procedure. 3. Patient was marijuana user (including smokeless, vaporized, etc.) within 4-weeks preceding their index procedure. 4. Patient had previously undergone radiation therapy to the chest wall prior to index surgery. Additional prospective inclusion criteria (if applicable): 1. Patient agrees to return in-person for prospective portion including the completion of photographs. Additional prospective exclusion criteria (if applicable): 1. Patient has a history of a psychological condision, drug or alcohol abuse which may interfere with their ability to adhere to the follow-up requirements. |
Country | Name | City | State |
---|---|---|---|
United States | Y Plastic Surgery | Alpharetta | Georgia |
United States | Plastic Surgery Consultants | Columbia | South Carolina |
United States | Stong Memorial Hospital | Rochester | New York |
United States | Janineh Plastic Surgery | Rochester Hills | Michigan |
United States | Dermatology Associates of San Antonio/Baptist Medical Center | San Antonio | Texas |
United States | Houston Methodist The Woodlands Hospita | The Woodlands | Texas |
Lead Sponsor | Collaborator |
---|---|
Tela Bio Inc | MCRA |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation. | Retrospective - Prospective assessment | 24 months | |
Primary | Narcotic usage | Retrospective - Prospective assessment | 24 months | |
Primary | Hospitalization length of stay | Retrospective - Prospective assessment | At procedure | |
Secondary | Time to Expander/Implant Exchange | Retrospective - Prospective assessment | 24-months | |
Secondary | Intraoperative Fill Volume / Number and Volume of Fill Visits | Retrospective - Prospective assessment | 24 months | |
Secondary | Independent aesthetic assessment of each treated breast as measured by Telemark Breast Score | Image aesthetic assessment | 24 months | |
Secondary | Independent assessment of breast ptosis as measured by the Rainbow Scale | Retrospective - Prospective assessment | 24-months |
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