Breast ReconstructionRESTORENCT07135596
Effectiveness and Safety of OviTex® PRS in Breast Reconstruction
A study testing OviTex PRS in people with Breast Reconstruction, run by Tela Bio Inc at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of OviTex PRS in subjects undergoing implant-based breast reconstruction. Read more about this study
- Who is it for?
- Ages 22 to 75 years, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- OviTex PRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Apr 2026to Jun 2034
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Qualmedica Research
Bowling Green, Kentucky, 42101
Troy Gunter, 270-904-4334, troy.gunter@qualmedicaresearch.com
Katherine Durnen, MD
- Recruiting
WakeMed
Raleigh, North Carolina, 27610
Rhonda Norton, 919-350-5252, rnorton@wakemed.org
Corianne Rogers, MD
- Recruiting
University of South Florida Plastic Surgery
Tampa, Florida, 33606
Michelle Beck, 813-660-6650, mbeck@tgh.org
Lauren Kuykendall, MD
About this study
Official title: Research on the Effectiveness and Safety of Treatment With OviTex® PRS - a Breast Reconstruction Evaluation
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
- Being tested
- OviTex PRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OviTex PRSDevice
A multi-layer construct of extracellular matrix (ECM) derived from ovine forestomach and embroidered with polymer filament.
| Study group | Role | What they receive |
|---|---|---|
| OviTex PRS | Experimental | Not described Receives: Device: OviTex PRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reconstructive Failure Rate
Measured: From enrollment to 12 months
Major Complication Rate
Measured: From enrollment to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start10 Apr 2026
- Primary completionJun 2030 (estimated)
- Study completionJun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tela Bio Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135596
- Sponsor's protocol ID
- TB_05
- Acronym
- RESTORE
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No