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临床试验/NCT04394468
NCT04394468已完成不适用

The Use of plasmaJet During Operative Laparoscopy for Endometriosis

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2020年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
feasibility of the PlasmaJet instrument

研究概览

简要总结

Endometriosis is a condition where functional endometrial tissue is present outside the uterus. It usually locates in the pelvis, which often includes the ovaries. One of the main concerns when performing surgery is to maintain fertility.

Nevertheless, a disadvantage of using monopolar and bipolar instruments for laparoscopic excision or coagulation of endometriosis lesions is the energy / thermal distribution that can cause damage to the surrounding healthy tissue. Therefore, the use of ultrasound, laser or plasma energy can potentially reduce damage to surrounding tissues and prevent adhesion formation. In addition, ablation of the internal surface of endometriomas can be an effective alternative to cystectomy.

The PlasmaJet system uses argon plasma which is released as kinetic, light and / or thermal energy. In this way the instrument can be applied within three functions, namely cutting, vaporizing and coagulating. Moreover, plasma will dissipate very quickly upon contact with tissue which consequently allows a controlled depth of tissue penetration. Thirdly, pure plasma energy differs from conventional electrosurgery since no electrical current will be spread through the tissue and therefore the thermal effect at surrounding tissues remains minimal.

The aim of this pilot study is to investigate the feasibility, effectiveness and safety of plasma energy in the treatment of endometriosis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women between 18 and 45 years old.
  • The presence of endometriosis; requiring surgical laparoscopy.

排除标准

  • Women younger than 18 years.
  • Women older than 45 years.
  • Women who are scheduled for surgical laparoscopy where the removal of the uterus and / or ovaries is needed.
  • Women who do not give written permission to participate.

结局指标

主要结局

feasibility of the PlasmaJet instrument

时间窗: During laparoscopic surgery

The surgeon's satisfaction with the use of plasma energy (5-point Likert scale).

effectiveness of the PlasmaJet instrument

时间窗: During laparoscopic surgery

- Whether or not to use additional instruments to achieve hemostasis (monopolar or bipolar coagulation) and / or complete resection of the lesions (monopolar or ultrasonic energy).

safety of the PlasmaJet instrument

时间窗: During laparoscopic surgery until six weeks after surgery

- Need for conversion to laparotomy.

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 (2)

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