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Tests treatment safety and results for Breast Reconstruction
Official title Effectiveness and Safety of OviTex® PRS in Breast Reconstruction
ClinicalTrials.gov ID: NCT07135596
What this study is testing
- What it's testing
- The purpose of this study is to evaluate the safety and effectiveness of OviTex PRS in subjects undergoing implant-based breast reconstruction.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 75, women only
You may be able to join 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...
- 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...
You likely can't join if
- Patient has a BMI \ 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...
- Breast reconstruction plan includes a custom sized breast implant, permanent breast implant greater than 800cc, and/or a permanent breast implant...
- Patient has undergone prior breast reconstruction, breast augmentation, mastopexy, or breast reduction surgeries (not including breast biopsy);
- Patient is undergoing delayed reconstruction;
See the full eligibility 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.
- Patient has a BMI \ 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...
- 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 people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bowling Green, Kentucky, United States
- Raleigh, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 22 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bowling Green, Kentucky, United States; Raleigh, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.