NCT01256502已完成不适用
The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery
Sofregen Medical, Inc.1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2010年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months
研究概览
简要总结
The purpose of the study is to obtain clinical experience with the use of SERI® Surgical Scaffold for tissue support and repair in 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •To be eligible for enrollment, the subject must:
- •Be female, greater or equal to 18 years of age
- •Be willing to undergo breast reconstruction with sub-pectoralis muscle placement of a tissue expander, followed by exchange with a sub-pectoral breast implant
- •Have previously had or be willing to undergo mastectomy with healthy, well-vascularized skin flaps anticipated by the surgeon
- •Be in good health other than breast pathology and be suited to general anesthesia and planned treatments.
排除标准
- •The subject must not:
- •Have undergone breast radiation treatment and/or is preoperatively evaluated to require radiation treatment to the breast area during the course of the study
- •Have a known allergy to silk
- •Have collagen-vascular, connective disease, or bleeding disorders
- •Have a Body Mass Index (BMI) that is greater than or equal to 35
- •Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
- •Have an autoimmune disease, an immune deficiency, or is on immune suppression drugs other than any other current treatment for breast cancer
- •Have smoked within the last 12 months
- •Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit
- •Be pregnant, lactating, or expecting to be within the next 24 months
- •Have concomitant unrelated condition of breast/chest wall/skin
- •Have an abscess or infection at the time of surgery
- •Have undergone previous breast surgery with the exception of mastectomy, breast biopsy, cyst removal, lumpectomy, mastopexy, reduction and/or augmentation
- •Have had a prior soft tissue support device implanted in the breast
- •Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
结局指标
主要结局
Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months
时间窗: 6 months
The primary outcome measure was investigator satisfaction at 6 months after stage I surgery/implantation of SERI® Surgical Scaffold. Satisfaction was evaluated using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.
次要结局
- Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery(Immediately following Stage I surgery)
- Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points(Stage 2 Surgery, Months 12, 18 and 24)
研究者
研究点 (1)
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