Evaluating the safety of OviTex PRS in breast reconstruction
A Retrospective Assessment of OviTex PRS (OviTex) Permanent and Resorbable Devices in Subjects Who Have Previously Undergone a Breast Reconstruction
This study is testing the safety of a new type of implant called OviTex PRS for people who have had breast reconstruction surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Tela Bio Inc Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 11 sites (Naples, Florida and 10 other locations) |
| Trial ID | NCT05736848 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety profile of OviTex PRS in patients who have undergone implant-based breast reconstruction. It includes a retrospective-prospective design, analyzing data from multiple centers where patients received either Permanent or Resorbable OviTex implants during their reconstruction procedures. The study focuses on both immediate and two-stage unilateral or bilateral implant placements, with the goal of informing future prospective studies on effectiveness endpoints.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 75 who have received OviTex PRS implants during their breast reconstruction procedures.
Not a fit: Patients who have received textured permanent breast implants or have a history of nicotine use or prior radiation therapy to the chest wall may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety of OviTex PRS, potentially leading to improved outcomes in breast reconstruction surgeries.
How similar studies have performed: While this study is observational and builds on existing knowledge, similar studies evaluating safety profiles of surgical devices have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient was between 18 years and 75 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 has undergone their initial surgical procedure and exchange surgery (if applicable). Exclusion Criteria: 1. Patient received a textured permanent breast implant. 2. Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding their index procedure. 3. 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.
Where this trial is running
Naples, Florida and 10 other locations
- Aesthetic Surgery Center — Naples, Florida, United States (Recruiting)
- Castrellon Aesthetic Surgery — South Miami, Florida, United States (Recruiting)
- Y Plastic Surgery — Alpharetta, Georgia, United States (Active_not_recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Janineh Plastic Surgery — Rochester Hills, Michigan, United States (Completed)
- David L. Abramson, MD — Englewood, New Jersey, United States (Recruiting)
- Capital Health — Pennington, New Jersey, United States (Recruiting)
- Strong Memorial Hospital — Rochester, New York, United States (Completed)
- Plastic Surgery Consultants — Columbia, South Carolina, United States (Recruiting)
- Dermatology Associates of San Antonio/Baptist Medical Center — San Antonio, Texas, United States (Completed)
- Houston Methodist The Woodlands Hospital — The Woodlands, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Asaf Yalif, MD — Y Plastic Surgery
- Study coordinator: Zachary Sterner
- Email: zsterner@telabio.com
- Phone: 937-514-2262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.