Raleigh, NCNCT07135596Now EnrollingIRB Ready

Breast Reconstruction Clinical Trial in Raleigh, NC

Access cutting-edge breast reconstruction treatment through this clinical trial at a research site in Raleigh. Study-provided care at no cost to qualified participants.

Sponsored by Tela Bio Inc

Quick Self-Assessment

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Expert Care in Raleigh

Access breast reconstruction specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related breast reconstruction treatment provided free

Apply for This Raleigh Location

Check if you qualify for this breast reconstruction clinical trial in Raleigh, NC

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Raleigh

    Convenient for NC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Raleigh site if eligible
  4. 4Begin participation

About This Breast Reconstruction Study in Raleigh

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

Sponsor: Tela Bio Inc

Who Can Participate

Inclusion Criteria

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.

Exclusion Criteria

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;
Patient is currently diagnosed with drug or alcohol abuse or has a known history with relapse within the past 3 years;
Patient is currently participating in another drug or device clinical trial;
Patient is currently imprisoned. Intraoperative Exclusion Criteria All subjects will be evaluated intraoperatively for the following exclusion criteria:
Subject does not receive an immediate pre-pectoral direct-to-implant breast reconstruction;
Study device will not be used during the procedure or a non-eligible device will be implanted.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Raleigh?

Yes, this clinical trial (NCT07135596) has an active research site in Raleigh, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Breast Reconstruction Treatment Options in Raleigh, NC

If you're searching for breast reconstruction treatment options in Raleigh, NC, this clinical trial (NCT07135596) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Raleigh research site is actively enrolling participants for this clinical trial. You'll receive care from experienced breast reconstruction specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all breast reconstruction clinical trials near you to find additional studies recruiting in your area.

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