临床试验/NCT06414083

NCT06414083招募中不适用

Histologic Comparison of Ablative Techniques for Endometriosis - a Randomized Trial

TriHealth Inc.2 个研究点分布在 1 个国家目标入组 141 人开始时间: 2024年5月9日最近更新: 2024年5月30日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: TriHealth Inc.
入组人数: 141
试验地点: 2
主要终点: Positive Histology

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To our knowledge, no other human studies directly compare the effectiveness of the various ablative technologies. We set out to design a study to directly compare ablative energy sources and evaluate their ability to destroy native endometriosis tissue in humans.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single (Outcomes Assessor)

盲法说明

Pathologist is blinded to treatment arm

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

•Adult women 18 years of age or older
•Already planning to undergo scheduled robotic assisted or laparoscopic excision of lesions for pelvic pain symptoms (pelvic pain, dysmenorrhea, dyspareunia, dysuria, dyschezia, ovarian pain) or endometriosis of any kind (endometriosis of any location, or endometrioma)

排除标准

•Known pregnancy at enrollment or at the time of the excision surgery

结局指标

主要结局

Positive Histology

时间窗: 0 days

Endometriosis seen on pathologic sample.

次要结局

Pelvic Pain(3 months)

研究者

发起方

TriHealth Inc.

申办方类型

Other

责任方

Sponsor

研究点 (2)

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