NCT01389232已完成不适用
The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe
Sofregen Medical, Inc.5 个研究点 分布在 4 个国家目标入组 104 人开始时间: 2011年6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
- 104
- 试验地点
- 5
- 主要终点
- Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale
研究概览
简要总结
This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.
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
- •Be female, greater or equal to 18 years of age
- •Be willing to undergo immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant
- •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
- •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 any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
- •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 With Seri® Surgical Scaffold on an 11-Point Scale
时间窗: Month 6
Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied.
次要结局
- Breast Anatomy Measurements(Preoperative, First Postoperative, Month 3, Month 6, Month 12, Month 18, Month 24)
- Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale(Month 3, Month 12, Month 18, Month 24)
- Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale(Immediately Following Stage 1 Surgery)
- Subject Satisfaction With Breasts on a 5-Point Scale(Baseline, Month 6, Month 12, Month 18, Month 24)
研究者
研究点 (5)
Loading locations...
相似试验
已完成
不适用
SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support and Repair in Breast ReconstructionBreast ReconstructionNCT01914653Sofregen Medical, Inc.17
已完成
不适用
The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction SurgeryBreast ReconstructionNCT01256502Sofregen Medical, Inc.160
终止
不适用
SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia RepairVentral Hernia RepairNCT01981044Sofregen Medical, Inc.1
已完成
不适用
SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation SurgerySubjects Requiring Revision Breast Augmentation SurgeryNCT02030938Sofregen Medical, Inc.34
已完成
不适用
Soft Tissue Graft for Repair of Pelvic Organ ProlapsePelvic Organ ProlapseNCT01827774Cook Group Incorporated31