用于组织塑形的患者专用模具的交互式设计
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.
研究概览
详细说明
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.
To collect information on the type of revisions for aesthetic purposes required in control versus intervention group.
To assess the number and type of complications experienced in control versus intervention group.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Ashleigh M Francis, MD
- 电话号码：713-563-4598
- 邮箱：amfrancis@mdanderson.org
学习地点
-
-
Texas
-
Houston、Texas、美国、77030
- 招聘中
- The University of Texas M. D. Anderson Cancer Center
-
接触：
- Ashleigh M Francis, MD
- 电话号码：713-563-4598
- 邮箱：amfrancis@mdanderson.org
-
首席研究员：
- Ashleigh M Francis, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intraoperative Use of 3D Printed Breast Mold
Participants will be randomized using a 1:1 ration to 1 of 2 conditions |
Participants will receive standard of care reconstruction |
|
实验性的：Standard of Care Reconstruction
Participants will be randomized using a 1:1 ration to 1 of 2 conditions |
Participants will undergo surgery. The surgeon may utilize the custom breast mold in shaping the autologous tissue flap for particiapnts. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Safety and Adverse eEents (AEs)
大体时间：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 |
Through study completion; an average of 1 year.
|
合作者和调查者
调查人员
- 首席研究员：Ashleigh M Francis, MD、M.D. Anderson Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2024-0265
- NCI-2024-09605 (其他标识符：NCI-CTRP Clinical Trials Registry)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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