A Prospective, Multi-center Study of the Effectiveness and Safety of OviTex® PRS in Breast Reconstruction (RESTORE)

Tela Bio

Status: Begins enrollment in 3 months

Conditions: Breast Reconstruction

Treatments: Device: OviTex PRS

Study type: Interventional

Funder types: Industry

Identifiers

NCT07135596

TB_05

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of OviTex PRS in subjects undergoing implant-based breast reconstruction.

Enrollment: 235 estimated patients

Sex: Female

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

235 participants in 1 patient group

Treatment Arm

Experimental group

Treatment:

Device: OviTex PRS