Treatment of Missed Miscarriage With TRUCLEAR Tissue Removal System, a Feasiblity Study
Condition: Miscarriage
MeSH terms: Abortion, Spontaneous
Study type: Interventional

Summary: 
      the Aim of this study is to prospectively study the feasibility of evacuation of products of
      conception (POC) in missed miscarriages up to 10 weeks using the TRUCLEAR tissue removal
      system in order to achieve targeted treatment under direct vision of the POC and thus
      potentially reducing the risk of complications and intrauterine adhesions
    

Detailed description: 
      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 sack allows us to document and
      describe the fetal morphology and to note different anatomical malformations. Phillips et al.
      described in 2001 the use of embryoscopy 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. This group also demonstrated that patients with repeated
      pregnancy loss are more likely to have morphologically normal embryos and less aneuploidy in
      cytogenetic analysis. The use of fetal tissue obtained in embryoscopy allows for more
      accurate genetic testing and diagnosis and reduces the number 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 allow for 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 the removal of 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.

      Use of the hysteroscopic morcellator for resection of the fetal tissue in early missed
      abortions 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 in one case for a woman with
      previous Ashreman's syndrome and was found to be feasible although the authors state that
      visibility was poor while resecting the implantation site due to high vascularization.

      The primary aim of the current study is to assess the feasibility of embryolysis - resection
      of an early missed abortion with the Truclear 8 mm hysteroscopic morcellator.

      Secondary aims include the rate of complications, incomplete removal and intrauterine
      adhesions.

      In this pilot feasibility study, we hypothesize that the 8mm Truclear Morcellator 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.
    

Intervention name(s): TRUCLEAR tissue removal system
Intervention type(s): Device
Intervention description(s): evacuation of POC using the TRUCLEAR tissue removal system
Other intervention name(s): non
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment