OviTex PRS for immediate implant-based breast reconstruction

Research on the Effectiveness and Safety of Treatment With OviTex® PRS - a Breast Reconstruction Evaluation

This trial will test whether using OviTex PRS is safe and improves outcomes for people having immediate pre-pectoral implant breast reconstruction after mastectomy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 235 (estimated)
• Ages: 22 Years to 75 Years
• Sex: Female
• Sponsor: Tela Bio Inc (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Raleigh, North Carolina)
• Trial ID: NCT07135596 on ClinicalTrials.gov

What this trial studies

This interventional study implants the OviTex PRS mesh as part of first-time, immediate direct-to-implant (DTI) pre-pectoral breast reconstruction following mastectomy. Eligible participants are adult women scheduled for unilateral or bilateral reconstruction who meet BMI and smoking-status criteria and consent to follow-up visits, questionnaires, clinic exams, and standardized photographs. Outcomes will include measures of safety (complications, adverse events) and clinical performance related to implant support and wound healing over the postoperative follow-up period. Data collection will be performed at a single investigational site with protocol-driven visits and documentation.

Who should consider this trial

Good fit: Women aged 22–75 undergoing first-time immediate unilateral or bilateral direct-to-implant pre-pectoral reconstruction after mastectomy, who are non-smokers, meet BMI criteria, and are willing to complete follow-up visits and questionnaires are ideal candidates.

Not a fit: Patients who smoke, have BMI below 18.5 or above 35, require radical mastectomy, plan hybrid coverage with other meshes or large autologous flaps, or need revision rather than first-time reconstruction are unlikely to be eligible or benefit from this protocol.

Why it matters

Potential benefit: If successful, OviTex PRS could reduce implant-related complications and improve soft-tissue support and cosmetic outcomes in immediate implant-based breast reconstruction.

How similar studies have performed: Other studies of acellular dermal matrices and reinforced tissue matrices for implant-based reconstruction have shown promising but variable results, while data specifically on OviTex PRS are more limited.

Eligibility criteria

Inclusion Criteria:

1. Patient is a female between the ages of 22 - 75, inclusive, at the time of enrollment (e.g. date of index surgical procedure);
2. Patient is planned for a first-time immediate unilateral or bilateral DTI pre-pectoral breast reconstruction following mastectomy for cancer or as cancer prophylaxis;
3. Patient is not a current cigarette smoker;
4. Patient is willing and able to voluntarily sign the IRB approved Subject Informed Consent Form;
5. Patient is willing and able to comply with the study requirements including completion of required follow-up visits, subject questionnaires, clinic evaluations, and photographs.

Exclusion Criteria:

1. Patient has a BMI \< 18.5 or \> 35;
2. Patient is undergoing radical mastectomy;
3. Breast reconstruction plan includes hybrid implant coverage using another type of mesh (synthetic or ADM) or another autologous treatment such as large latissimus flap, abdominal flap or similar;
4. Breast reconstruction plan includes a custom sized breast implant, permanent breast implant greater than 800cc, and/or a permanent breast implant that is not FDA approved for use in breast reconstruction;
5. Patient has undergone prior breast reconstruction, breast augmentation, mastopexy, or breast reduction surgeries (not including breast biopsy);
6. Patient is undergoing delayed reconstruction;
7. Patient has received neo-adjuvant radiation to the chest (including any previous history of whole breast radiation or mantle radiation);
8. Patient has received neo-adjuvant chemotherapy within the 4 weeks prior to enrollment;
9. Patient has received Keytruda therapy or is planning to receive Keytruda therapy during study participation;
10. Patient has uncontrolled Type I or Type II diabetes (HbA1C \>7%);
11. Patient is pregnant or planning to become pregnant during study participation and up to 5 years from the index surgical procedure;

    • If the subject is not post-menopausal, agree to take adequate birth control precautions during study participation;
12. Patient has been diagnosed with a medical condition or is taking medications which are known to impact wound healing, weaken the body's natural resistance to disease, result in elevated postoperative risks, or may otherwise affect the validity of the study;
13. Patient has a known sensitivity or allergy to poly(lactic-co-glycolic acid) (PLGA) or materials of ovine (sheep) origin;
14. Patient is diagnosed with a bleeding disorder in which medication is not stopped within 2 weeks of the index procedure;
15. Patient is currently diagnosed with drug or alcohol abuse or has a known history with relapse within the past 3 years;
16. Patient is currently participating in another drug or device clinical trial;
17. Patient is currently imprisoned.

Intraoperative Exclusion Criteria

All subjects will be evaluated intraoperatively for the following exclusion criteria:

1. Subject does not receive an immediate pre-pectoral direct-to-implant breast reconstruction;
2. Study device will not be used during the procedure or a non-eligible device will be implanted.

Where this trial is running

Raleigh, North Carolina

• WakeMed — Raleigh, North Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Senior Clinical Project Manager

Conditions Breast Reconstruction