RecruitingNot Applicable

Effectiveness and Safety of OviTex® PRS in Breast Reconstruction

United States235 participantsStarted 2026-04-10

Plain-language summary

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

Age range22 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. Patient has a BMI \< 18.5 or \> 35;
✕. Patient is undergoing radical mastectomy;
✕. 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;
✕. 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;
✕. Patient has undergone prior breast reconstruction, breast augmentation, mastopexy, or breast reduction surgeries (not including breast biopsy);
✕. Patient is undergoing delayed reconstruction;
✕. Patient has received neo-adjuvant radiation to the chest (including any previous history of whole breast radiation or mantle radiation);
✕. Patient has received neo-adjuvant chemotherapy within the 4 weeks prior to enrollment;

Reconstructive Failure Rate

Timeframe: From enrollment to 12 months

Major Complication Rate

Timeframe: From enrollment to 12 months

NCT IDNCT07135596

SponsorTela Bio Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-06

Senior Clinical Project Manager

Who can participate

Age range22 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. Patient has a BMI \< 18.5 or \> 35;
✕. Patient is undergoing radical mastectomy;
✕. 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;
✕. 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;
✕. Patient has undergone prior breast reconstruction, breast augmentation, mastopexy, or breast reduction surgeries (not including breast biopsy);
✕. Patient is undergoing delayed reconstruction;
✕. Patient has received neo-adjuvant radiation to the chest (including any previous history of whole breast radiation or mantle radiation);
✕. Patient has received neo-adjuvant chemotherapy within the 4 weeks prior to enrollment;