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Completed

NCT Number: NCT04512820

Treatment of Missed Miscarriage With TRUCLEAR Tissue Removal System, a Feasiblity Study

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

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Key information

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assuta Ashdod University Hospital

Ashdod, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with missed miscarriage up to 10 weeks from the last menstrual period
  • Patients are able to provide written consent
  • Patients with no underlying medical conditions

Exclusion criteria

  • Inability to consent due to cognitive or language barrier
  • Any underlying medical condition requiring medical treatment
  • Documented failed hysteroscopy prior to the current referral
  • Inability to consent due to cognitive or language barrier
  • Uterine malformations or fibroids
  • Previous cesarean section

Treatment and study plan

TRUCLEAR tissue removal system

Device

evacuation of POC using the TRUCLEAR tissue removal system

Other names: non

Primary outcomes

  1. Number of cases with retained products of conception following the procedure

    Time frame: immediate - during the procedure

    Number of cases in which the procedure could not be completed using under vision hysteroscopic morcellation

Secondary outcomes

  1. number of complications according to Dindo-Clavien scale

    Time frame: within six weeks from the procedure

    number of any complications according to the Dindo-Clavien scale, especially uterine perforation, infection, bleeding and pain that requires admission

  2. incomplete removal

    Time frame: within 8 weeks

    number of patients with retained products of conception on ultrasound scan or hysteroscopy

Sponsors and collaborators

Lead sponsor

Assuta Ashdod Hospital

Other

Registry information

Official study title

Embryoscopic Evacuation of Early Missed Abortion Using the TRUCLEAR Hysteroscopic Morcellator System a Feasibility Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 14, 2020
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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