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临床试验/NCT04319653
NCT04319653终止不适用

Development of a Pelvic Cavity Characterization Algorithm Through the Acquisition of MRI Images and Pressure Measurement by an Intravaginal Probe

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2021年4月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
1
试验地点
1
主要终点
3D reconstruction of the pelvic cavity

研究概览

简要总结

The conditions such as childbirth or endometriosis can lead to a change in the mobility of the pelvic organs (bladder, vagina, rectum and uterus). The purpose of the study is to study in a personalized way each woman the characteristics of the tissues of their pelvis and to be able to personalize the treatments (surgery, injection, rehabilitation, etc.). Women requiring pelvic MRI may participate in the study. The pelvic dynamic MRI will be done with an intravaginal probe which will be inserted by the patient herself as well as gel in the anus and vagina which will allow to obtain the data on the characteristics of the pelvic tissues of each woman with a 3D reconstruction.

研究设计

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

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

  • Understanding of the French language
  • Signature of informed consent
  • Insured social patient
  • For pregnant women:
  • Primiparous women
  • with no severe maternal-fetal pathology
  • with no scheduled caesarean section at the time of the MRI
  • For women with prolapse:
  • - Requires pelvic MRI

排除标准

  • Person who does not have social security
  • Person with ongoing vaginal infection
  • Pregnant woman during the first or third trimester of pregnancy
  • Pregnant woman with broken water pocket
  • Bi-cicatricial uterus
  • Person wearing a pace maker or any intra-body metal implant (if "tube" MRI)
  • Claustrophobic person (if "tube" MRI)

结局指标

主要结局

3D reconstruction of the pelvic cavity

时间窗: at 1 month

Characterization of the pelvic cavity through a double assessment: a pelvic MRI sequence and an intravaginal pressure probe.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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