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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04512820
Recruitment Status : Recruiting
First Posted : August 14, 2020
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
Assuta Ashdod Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Miscarriage Device: TRUCLEAR tissue removal system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Embryoscopic Evacuation of Early Missed Abortion Using the TRUCLEAR Hysteroscopic Morcellator System a Feasibility Study
Actual Study Start Date : March 5, 2020
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

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 Name: non




Primary Outcome Measures :
  1. completion of the procedure [ Time Frame: immediate - during the procedure ]
    completion of the procedure undervision without need to resort to suction & curettage


Secondary Outcome Measures :
  1. complications [ Time Frame: within two weeks from the procedure ]
    uterine perforation, infection, bleeding and pain that requires admission

  2. incomplete removal [ Time Frame: within 8 weeks ]
    presence of retained products of conception on ultrasound scan or hysteroscopy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04512820


Contacts
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Contact: Oshri Barel, MD +927559382117 Oshrib@assuta.co.il

Locations
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Israel
Assuta Ashdod University Hospital Recruiting
Ashdod, Israel
Contact: Oshri Barel, MD    +972559382117    oshrib@assuta.co.il   
Principal Investigator: Oshri Barel, MD         
Sponsors and Collaborators
Assuta Ashdod Hospital
Publications:

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Responsible Party: Assuta Ashdod Hospital
ClinicalTrials.gov Identifier: NCT04512820    
Other Study ID Numbers: 005-20-AAA
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: only unidentified data will be shared

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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
Additional relevant MeSH terms:
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Abortion, Spontaneous
Pregnancy Complications