🏛️ Verified NIH Record • Updated 2026-05-29
Effectiveness and Safety of OviTex® PRS in Breast Reconstruction (NCT07135596)
Research on the Effectiveness and Safety of Treatment With OviTex® PRS - a Breast Reconstruction Evaluation
🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Tela Bio Inc
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to evaluate the safety and effectiveness of OviTex PRS in subjects undergoing implant-based breast reconstruction.
Who can join: Review the eligibility criteria below.
Location: Qualmedica Research — Bowling Green, Kentucky
Age range: 22 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- Qualmedica Research — Bowling Green, Kentucky
- WakeMed — Raleigh, North Carolina
📞 Contact the Study Coordinator
Phone: (484) 320-2930
Email: telaclinicalresearch@telabio.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Breast Reconstruction
- Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC — Boston, Massachusetts
- A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction — Montgomery, Alabama
- Acellular Dermal Matrix Investigation in Breast Reconstruction — Little Rock, Arkansas
- Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants — Los Angeles, California
- Access My Breast Cancer Care App — Vancouver, British Columbia
- Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction — Boston, Massachusetts
Explore by condition: All Breast Reconstruction clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.