Actively Recruiting

Phase Not Applicable
Age: 22Years - 75Years
FEMALE
NCT07135596

Effectiveness and Safety of OviTex® PRS in Breast Reconstruction

Led by Tela Bio Inc · Updated on 2026-05-06

235

Participants Needed

1

Research Sites

424 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Effectiveness and Safety of OviTex® PRS in Breast Reconstruction

Who Can Participate

Age: 22Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 22 to 75 years at 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 sign informed consent
  • Able to comply with study visits, questionnaires, evaluations, and photographs
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) less than 18.5 or greater than 35
  • Undergoing radical mastectomy
  • Plan includes hybrid implant coverage using other mesh types or autologous treatments like large latissimus or abdominal flaps
  • Use of custom sized breast implant, permanent implant over 800cc, or implant not FDA approved for breast reconstruction
  • Prior breast reconstruction, augmentation, mastopexy, or breast reduction surgeries (excluding biopsy)
  • Undergoing delayed reconstruction
  • Received neo-adjuvant chest radiation or whole breast/mantle radiation
  • Received neo-adjuvant chemotherapy within 4 weeks before enrollment
  • Received or planning to receive Keytruda therapy during study
  • Uncontrolled Type I or II diabetes (HbA1C >7%)
  • Pregnant or planning pregnancy during study and up to 5 years after surgery; if not post-menopausal, agrees to birth control during study
  • Diagnosed with conditions or taking medications affecting wound healing, immune resistance, or increasing postoperative risks
  • Known allergy or sensitivity to PLGA or ovine materials
  • Diagnosed bleeding disorder without stopping medication 2 weeks before surgery
  • Current drug or alcohol abuse or relapse within past 3 years
  • Currently in another drug or device clinical trial
  • Currently imprisoned
  • Intraoperative exclusions: no immediate pre-pectoral direct-to-implant reconstruction 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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

WakeMed

Raleigh, North Carolina, United States, 27610

Actively Recruiting

Loading map...

Research Team

S

Senior Clinical Project Manager

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here