Effectiveness and Safety of OviTex® PRS in Breast Reconstruction

NCT07135596 | Recruiting DMC FDA Device

• 1 other identifier: TB_05
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Reconstruction

Outcome Measures

Primary Outcomes (2)

• Reconstructive Failure Rate

  From enrollment to 12 months

• Major Complication Rate

  From enrollment to 12 months

Study Arms (1)

OviTex PRS

EXPERIMENTAL

Device: OviTex PRS

Interventions

OviTex PRS DEVICE

A multi-layer construct of extracellular matrix (ECM) derived from ovine forestomach and embroidered with polymer filament.

OviTex PRS

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Patient has received Keytruda therapy or is planning to receive Keytruda therapy during study participation;
• Patient has uncontrolled Type I or Type II diabetes (HbA1C \>7%);
• 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;
• 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;
• Patient has a known sensitivity or allergy to poly(lactic-co-glycolic acid) (PLGA) or materials of ovine (sheep) origin;
• Patient is diagnosed with a bleeding disorder in which medication is not stopped within 2 weeks of the index procedure;

Sponsors & Collaborators

• Tela Bio Inc: lead

Study Sites (1)

WakeMed

Raleigh, North Carolina, 27610, United States

RECRUITING

Central Study Contacts

Senior Clinical Project Manager

CONTACT

484-320-2930; telaclinicalresearch@telabio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 22, 2025
• Study Start: April 10, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2034
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)