Interactive Design of Patient-Specific Molds for Tissue Shaping
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Safety and Adverse eEents (AEs)
研究概览
简要总结
The goal of this study is to develop clinical decision-support algorithms for designing participants-specific breast molds for tissue shaping. Autologous breast reconstruction is an important part of breast cancer rehabilitation for many participants. Our goal is to increase the efficiency of autologous breast reconstruction by helping the surgeon design participants-specific molds for shaping tissue into an acceptable breast form.
详细描述
Primary Objective:
To evaluate the efficiency of autologous reconstruction performed with 3D-printed participants-specific breast molds designed using our clinical decision-support algorithms.
Secondary Objectives:
To assess the total number of times the mold was used by the surgeons in the intervention group.
To compare the intraoperative time for shaping tissue in control versus intervention group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older
- •Patients who are willing and able to provide informed consent
- •Patients who are scheduled to undergo breast reconstruction with free flap (Deep Interior Epigastric Artery Perforator (DIEP) flap or Transverse Rectus Abdominis Myocutaneous (TRAM) flap)
排除标准
- •Patients whose surgical plan includes the use of stacked flaps (DIEP + other free flap, usually from the thigh or buttock)
- •Patients whose surgical plan includes the use of DIEP flap with vascularized lymph node transfer
- •Patients undergoing neoadjuvant radiation
研究组 & 干预措施
Standard of Care Reconstruction
Participants will be randomized using a 1:1 ration to 1 of 2 conditions
干预措施: Surgery, Breast Mold (Procedure)
Intraoperative Use of 3D Printed Breast Mold
Participants will be randomized using a 1:1 ration to 1 of 2 conditions
干预措施: Standard of care reconstruction (Procedure)
结局指标
主要结局
Safety and Adverse eEents (AEs)
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点