NCT06797258招募中不适用
Safety And Effectiveness Of FlexHD® Pliable Acellular Dermal Matrix In Implant-Based Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 259
- 试验地点
- 2
- 主要终点
- Frequency of major complication
研究概览
简要总结
Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females at least 22 years of age
- •Scheduled to undergo unilateral or bilateral mastectomy with immediate implant-based, prepectoral breast reconstruction
- •Willing to provide Informed Consent
- •Able to return for all required study visits
- •Must read and understand English language
排除标准
- •Is of childbearing potential and has a positive pregnancy test within 7 days of study procedure
- •Has a residual gross tumor at the intended reconstruction site
- •Has undergone previous breast surgery, such as lumpectomy or breast augmentation, at the site of implantation with the exception of a biopsy
- •Has undergone previous radiation therapy to the reconstruction site or chest wall, or is scheduled to undergo post-operative radiation therapy at the reconstruction site
- •Completed chemotherapy within 3 weeks prior to surgery
- •Has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications
- •Has a Body Mass Index (BMI) >35
- •Has used nicotine products within 1 month of screening
- •Must not have taken oral corticosteroids for a minimum of 1 month prior to the procedure or have a history of long-term use of systemic oral corticosteroids or anticipate the use during course of the study
结局指标
主要结局
Frequency of major complication
时间窗: 12 months
Complications that require additional hospitalization or reoperation
Frequency of reconstructive failure
时间窗: 12 months
Removal/explantation of the breast implant
次要结局
- Adverse events(12 months)
- Change in patient reported outcomes(12 months)
- Pain(12 months)
研究者
研究点 (2)
Loading locations...
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