Actively Recruiting
Research on the Effectiveness and Safety of Treatment With OviTex4 PRS in Breast Reconstruction Evaluation
Led by Tela Bio Inc · Updated on 2026-06-02
235
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of OviTex PRS, a device made from a multi-layer construct of extracellular matrix derived from ovine forestomach and embroidered with polymer filament, in patients undergoing implant-based breast reconstruction. The study focuses on women aged 22 to 75 who are having their first immediate unilateral or bilateral direct-to-implant pre-pectoral breast reconstruction after mastectomy for cancer or cancer prevention. The trial is sponsored by Tela Bio Inc and aims to monitor reconstructive failure and major complications over 12 months. Participants receive the OviTex PRS device during their breast reconstruction surgery. The study includes careful consideration of who can participate, excluding those with certain medical conditions, prior breast surgeries, or specific treatment histories. The trial does not involve blinding or placebo groups and follows patients for 12 months to assess outcomes after the surgery. During the study, participants will attend follow-up visits for clinic evaluations, complete questionnaires, and have photographs taken to track their progress. Researchers will measure reconstructive failure rates and major complications from enrollment through one year post-surgery. Participants must be able to comply with study visits and requirements, and safety monitoring will continue throughout the study duration.
CONDITIONS
Brief Title
Effectiveness and Safety of OviTex® PRS in Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is a female between the ages of 22 and 75 at the time of enrollment
- Planned first-time immediate unilateral or bilateral direct-to-implant pre-pectoral breast reconstruction after mastectomy for cancer or cancer prevention
- Not a current cigarette smoker
- Willing and able to voluntarily sign informed consent
- Able to comply with study requirements including follow-up visits, questionnaires, evaluations, and photographs
You will not qualify if you...
- Body mass index (BMI) less than 18.5 or greater than 35
- Undergoing radical mastectomy
- Breast reconstruction plan includes hybrid implant coverage using other mesh or autologous treatments like large latissimus or abdominal flaps
- Plan includes custom sized breast implant, permanent implant over 800cc, or implant not FDA approved for reconstruction
- Prior breast reconstruction, augmentation, mastopexy, or reduction surgeries (excluding biopsy)
- Undergoing delayed reconstruction
- Received neo-adjuvant chest radiation
- Received neo-adjuvant chemotherapy within 4 weeks before enrollment
- Received or planning to receive Keytruda therapy during participation
- Uncontrolled diabetes with HbA1C over 7%
- Pregnant or planning pregnancy during study and up to 5 years after surgery
- Not post-menopausal and unwilling to use birth control during study
- Diagnosed with conditions or on medications affecting wound healing or increasing postoperative risks
- Known allergy to PLGA or sheep-derived materials
- Bleeding disorder without stopping medication 2 weeks before surgery
- Current or recent drug or alcohol abuse with relapse within 3 years
- Participating in another drug or device clinical trial
- Currently imprisoned
- Intraoperative exclusion if immediate pre-pectoral direct-to-implant reconstruction not performed or study device not used or non-eligible device implanted
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgical procedure with immediate post-operative care
Participants undergo breast reconstruction surgery using the OviTex PRS device.
1 surgery and approximately 6 post-operative visits
Duration - Up to 12 months after surgery
Participants are monitored for safety and effectiveness outcomes including reconstructive failure and major complications.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 2 locations
1
Qualmedica Research
Bowling Green, Kentucky, United States, 42101
Actively Recruiting
2
WakeMed
Raleigh, North Carolina, United States, 27610
Actively Recruiting
Research Team
S
Senior Clinical Project Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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