ACTRN12623000505606进行中（未招募）Unknown
Pilot Evaluation of the ENIVO System in Simple Unilateral Mastectomy
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 21 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Patients will be considered eligible for the study based on the following criteria:
- •Willing and able to provide written informed consent and to comply with the requirements of the Clinical Investigational Plan.
- •Aged 21 years or above.
- •Undergoing simple unilateral mastectomy, with or without sentinel node biopsy and who would otherwise be receiving surgical drains as part of standard of care.
排除标准
- •Patients will be excluded from the study based on the following criteria:
- •Patients with known sensitivity to ovine (sheep) derived material, silicon, barium sulphate or synthetic suture materials.
- •Pregnant or lactating females.
- •Patients on steroids or other immune modulators known to impact healing.
- •Patients who are likely to not complete the study.
- •Patients who, in the opinion of the investigator, are unlikely to comply with the protocol.
- •Patients who have participated in this trial previously and who were withdrawn.
- •Any medical condition, recent treatment or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study, such as obesity (BMI>40), uncontrolled diabetes (HbA1c>53 mmol/mol), immunosuppression, or recent neoadjuvant chemotherapy or radiotherapy.
- •Patient is currently participating or has participated in another clinical study within past 30 days prior to enrolment.
- •Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study.
研究者
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