NCT04512820

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2021

Completed
Last Updated

August 23, 2023

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

August 11, 2020

Last Update Submit

August 20, 2023

Conditions

Miscarriage

Outcome Measures

Primary Outcomes (1)

  • Number of cases with retained products of conception following the procedure

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

    immediate - during the procedure

Secondary Outcomes (2)

  • number of complications according to Dindo-Clavien scale

    within six weeks from the procedure

  • incomplete removal

    within 8 weeks

Study Arms (1)

TRUCLEAR TREATMENT

EXPERIMENTAL

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

Interventions

TRUCLEAR tissue removal systemDEVICE

evacuation of POC using the TRUCLEAR tissue removal system

Also known as: non
TRUCLEAR TREATMENT

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuta Ashdod University Hospital

Ashdod, Israel

Location

Related Publications (7)

  • Philipp T, Kalousek DK. Transcervical embryoscopy in missed abortion. J Assist Reprod Genet. 2001 May;18(5):285-90. doi: 10.1023/a:1016666301481.

    PMID: 11464580BACKGROUND

  • Feichtinger M, Wallner E, Hartmann B, Reiner A, Philipp T. Transcervical embryoscopic and cytogenetic findings reveal distinctive differences in primary and secondary recurrent pregnancy loss. Fertil Steril. 2017 Jan;107(1):144-149. doi: 10.1016/j.fertnstert.2016.09.037. Epub 2016 Oct 12.

    PMID: 27743696BACKGROUND

  • Campos-Galindo I, Garcia-Herrero S, Martinez-Conejero JA, Ferro J, Simon C, Rubio C. Molecular analysis of products of conception obtained by hysteroembryoscopy from infertile couples. J Assist Reprod Genet. 2015 May;32(5):839-48. doi: 10.1007/s10815-015-0460-z. Epub 2015 Mar 17.

    PMID: 25779005BACKGROUND

  • Shazly SA, Laughlin-Tommaso SK, Breitkopf DM, Hopkins MR, Burnett TL, Green IC, Farrell AM, Murad MH, Famuyide AO. Hysteroscopic Morcellation Versus Resection for the Treatment of Uterine Cavitary Lesions: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):867-77. doi: 10.1016/j.jmig.2016.04.013. Epub 2016 May 7.

    PMID: 27164165BACKGROUND

  • Hooker A, Fraenk D, Brolmann H, Huirne J. Prevalence of intrauterine adhesions after termination of pregnancy: a systematic review. Eur J Contracept Reprod Health Care. 2016 Aug;21(4):329-35. doi: 10.1080/13625187.2016.1199795.

    PMID: 27436757BACKGROUND

  • Harpham M, Abbott J. Use of a hysteroscopic morcellator to resect miscarriage in a woman with recurrent Asherman's syndrome. J Minim Invasive Gynecol. 2014 Nov-Dec;21(6):1118-20. doi: 10.1016/j.jmig.2014.05.006. Epub 2014 May 24.

    PMID: 24865632BACKGROUND

  • Weinberg S, Pansky M, Burshtein I, Beller U, Goldstein H, Barel O. A Pilot Study of Guided Conservative Hysteroscopic Evacuation of Early Miscarriage. J Minim Invasive Gynecol. 2021 Nov;28(11):1860-1867. doi: 10.1016/j.jmig.2021.04.017. Epub 2021 May 2.

    PMID: 33951488DERIVED

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 14, 2020

Study Start

March 5, 2020

Primary Completion

January 12, 2021

Study Completion

January 12, 2021

Last Updated

August 23, 2023

Record last verified: 2020-01

Locations

IL(1)