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

August 20, 2023 updated by: Assuta Ashdod Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ashdod, Israel
        • Assuta Ashdod University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRUCLEAR TREATMENT
patients up to 10 weeks of gestation with missed miscarriage undergoing evacuation of products of conception using the TRUCLEAR tissue removal system under direct hysteroscopic visualization
Device: TRUCLEAR tissue removal system
evacuation of POC using the TRUCLEAR tissue removal system
Other Names:
  • non

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
immediate - during the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within six weeks from the procedure
incomplete removal
Time Frame: within 8 weeks
number of patients with retained products of conception on ultrasound scan or hysteroscopy
within 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assuta Ashdod Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2020

Primary Completion (Actual)

January 12, 2021

Study Completion (Actual)

January 12, 2021

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (Actual)

August 14, 2020

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 20, 2023

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 005-20-AAA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

only unidentified data will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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