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临床试验/NCT07205146
NCT07205146已完成不适用

Evolution of Symptoms After Treatment With System CavatermTM for Idiopathic Functional Menometrorraghia Contraceptive Implants

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
menometrorrhagia

研究概览

简要总结

The prevalence of menometrorrhagia is estimated at 11% to 13% in the general population and increases with age to reach 24% in 36-40 year olds. It is the leading cause of gynecological consultations. Considered benign, menometrorrhagia is responsible for anemia and impaired quality of life. It is the most common cause of iron deficiency anemia in premenopausal women.

The etiology of menometrorrhagia is varied. The main causes of menometrorrhagia are organic causes, iatrogenic causes, coagulopathies, hypothyroidism, and endometrial atrophy. In the majority of cases, no underlying pathology is found; they are then called functional idiopathic. This is a diagnosis of exclusion.

In idiopathic functional menometrorrhagia, the first-line treatment is medical. In the event of failure of medical treatment (in 50% of cases), in women who do not wish to maintain their reproductive possibilities, surgical treatment may be considered.

The Cavaterm™ system is a balloon-assisted endometrial ablation device. Treatment with Cavaterm™ involves removing the endometrium using a minimally invasive technique. The procedure is short-term and outpatient.

In this study, we aim to evaluate the Cavaterm™ system for the treatment of idiopathic functional menometrorrhagia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

menometrorrhagia

时间窗: at 2 months after treatment

rate of menometrorrhagia at 2 months after treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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