跳至主要内容
临床试验/EUCTR2015-000644-42-NL
EUCTR2015-000644-42-NL进行中(未招募)不适用

aparoscopic advanced Imaging Techniques in Endometriosis therapy: LITE-study. A pilot trial. - LITE study

VU University medical center (VUmc)0 个研究点开始时间: 2016年1月4日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • Oral and written informed consent
  • Age 18 years and older
  • Premenopausal women
  • Elective laparoscopic treatment of endometriosis lesions by CO 2 laser/ bipolar diathermy or surgical excision.
  • Presence of endometriosis (ASRM III-IV) confirmed by previous laparoscopy or likely to be present based on TVUS or MRI, including uni- or bilateral ovarian endometrioma.
  • Regular preoperative work-up
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 20
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • Women who are legally or mentally incapable or unable to give informed consent
  • Age younger than 18 years
  • ASA (American Society of Anaesthesiologists) score higher than 3
  • Woman who have had major open abdominal surgery
  • Pregnancy
  • Malignancy
  • Iodine allergy
  • Hypersensitivity reaction to prior usage of indocyanin green injection
  • Hyperthyroidism or autonomous thyroid adenoma
  • Chronic kidney failure (eGFR<55)
  • Chronic liver failure (ASAT, ALAT, AF and yGT > two times the max normal value)

研究者

发起方
VU University medical center (VUmc)

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