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临床试验/NCT04668547
NCT04668547Unknown不适用

Embryoscopic Evacuation for Induced Abortion Using TRUCLEAR Hysteroscopic Morcellator System

Oshri Barell1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
1
主要终点
Completion of the procedure

研究概览

简要总结

The investigators intend to assess if hysteroscopic evacuation of gestational tissue, is possible as a tool for early induced abortion with a hysteroscopic morcellator rather than with a traditional dilation and curettage procedure. The investigators hypothesize that induced abortion under vision with hysteroscopic guidance may provide benefits over the traditional "blind" procedure

详细描述

Embryoscopy and fetoscopy had been used increasingly in the treatment of missed abortions in the last two decades. This is done simply by transcervical hysteroscopy during pregnancy. The fact that we can directly view the embryo in the gestational sac allows us to document and describe the fetal morphology and to note different anatomical malformations. Phillips et al described in 2001 the use of embryoscpy prior to evacuation of the uterus in early missed abortions in order to diagnose anatomical malformations and to allow sampling of the fetal tissues for genetic testing. The use of fetal tissue obtained in embryoscopy allows for a more accurate genetic testing and diagnosis and reduces the amount of maternal cells in the specimen.

Hysteroscopic morcellation had been used for intrauterine tissue extraction for over 20 years. Hysteroscopic morcellators have been shown to provide rapid and complete resection of polyps, fibroids, uterine septa and retained products of conception. These instruments use a rotating blade and a suction system that allows for removal for the specimen under direct hysteroscopic visualization. When compared with standard resectoscopic technique, the use of hysteroscopic morcellators probably saves time and allows for more complete removal of the specimen.

A feasibility study conducted in our institute showed that the use of the hysteroscopic morcellator for resection of the fetal tissue in early missed abortions is feasible and safe and might prove beneficial over the standard blind Dilatation and curettage currently used to treat this condition. This technique might allow selective targeting of the fetal tissue thus decreasing the damage caused by trauma to the entire uterine cavity. In a recent systematic review the rate of intrauterine adhesions following D&C for missed abortions ranged between 16 to 21 percent. This technique was assessed prior to our study in only one case published in the literature and was found to be feasible, although the authors state that visibility was poor while resecting the implantation site due to high vascularization.

After demonstrating that hysteroscopic morcellation is possible in cases of early missed abortions, we suggest that the procedure will be possible and safe in cases of early induced abortions, with similar potential benefits.

In this pilot feasibility study, we hypothesize that the Truclear Elite tissue removal system will be able to achieve full evacuation of the uterine cavity. Performed under direct visualization and focused only on the implantation site, thus reducing the potential for further intrauterine adhesions.

研究设计

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

入排标准

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

入选标准

  • Women between the ages of 21 years - 45 years inclusive.
  • Referred for dilatation and curettage for induced abortion
  • Confirmed intrauterine pregnancy with gestational age of up to 9 weeks
  • At least one previous normal vaginal delivery with a healthy child
  • Patients are able to provide written consent
  • Patients with no underlying medical conditions

排除标准

  • Inability to consent due to cognitive or language barrier
  • Significant uterine bleeding, fever or incomplete abortion
  • Previous cesarean section
  • Sub-chorionic hematoma, Malformed uterus or Submucosal fibroids
  • Any underlying medical condition requiring medical treatment
  • Documented failed hysteroscopy prior to the current referral

结局指标

主要结局

Completion of the procedure

时间窗: During the procedure

Number of patients that were able to complete the procedure under vision without retained products of conception.

次要结局

  • Complications(within 30 days from the procedure)

研究者

发起方
Oshri Barell
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Oshri Barell

Head of Gynecology

Assuta Ashdod Hospital

研究点 (1)

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