NCT07135596招募中不适用
Research on the Effectiveness and Safety of Treatment With OviTex® PRS - a Breast Reconstruction Evaluation
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Tela Bio Inc
- 入组人数
- 235
- 试验地点
- 2
- 主要终点
- Reconstructive Failure Rate
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of OviTex PRS in subjects undergoing implant-based breast reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
OviTex PRS
Experimental
干预措施: OviTex PRS (Device)
结局指标
主要结局
Reconstructive Failure Rate
时间窗: From enrollment to 12 months
Major Complication Rate
时间窗: From enrollment to 12 months
次要结局
未报告次要终点
研究者
研究点 (2)
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