NCT06502353招募中不适用
A Pilot Study to Investigate the Use of the Plexaa Preconditioning Device (BLOOM43) for Gender Affirming Mastectomy - a Prospective Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Plexaa Ltd
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Participant experience
研究概览
简要总结
The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in transgender and non-binary patients undergoing gender affirming mastectomy. This study aims to understand a participant's experience of the device, including its usability and acceptability.
Participants will use the device to precondition their right breast the evening before undergoing surgery (gender affirming mastectomy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •All transgender or non-binary patients over the age of 18 years (no maximum age limit)
- •Patients undergoing peri-areolar mastectomy or double incision mastectomy with a free nipple graft for gender affirmation
排除标准
- •Patients undergoing surgery for breast cancer
- •Delayed (two-stage) breast reconstruction patients
- •Patients undergoing simple mastectomy or wide local excision of a breast tumour
- •Presence of open breast skin wounds, or infected or inflamed breast skin
- •Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device
结局指标
主要结局
Participant experience
时间窗: 30 days
Participants' experience of the device will be evaluated with the use of a questionnaire. Most of the questions will consist of multiple-choice components with a five-point scale and there will also be a section for further comments from participants.
次要结局
- Compliance(1 day)
- Nipple necrosis/nipple graft loss(30 days)
研究者
研究点 (2)
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