Treatment of Missed Miscarriage With TRUCLEAR Tissue Removal System, a Feasiblity Study
NCT ID: NCT04512820
Last Updated: 2023-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2020-03-05
2021-01-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
TRUCLEAR tissue removal system
evacuation of POC using the TRUCLEAR tissue removal system
Interventions
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TRUCLEAR tissue removal system
evacuation of POC using the TRUCLEAR tissue removal system
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients are able to provide written consent
* Patients with no underlying medical conditions
Exclusion Criteria
* 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
21 Years
45 Years
FEMALE
Yes
Sponsors
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Assuta Ashdod Hospital
OTHER
Responsible Party
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Locations
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Assuta Ashdod University Hospital
Ashdod, , Israel
Countries
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References
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Philipp T, Kalousek DK. Transcervical embryoscopy in missed abortion. J Assist Reprod Genet. 2001 May;18(5):285-90. doi: 10.1023/a:1016666301481.
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.
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.
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.
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.
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.
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.
Other Identifiers
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005-20-AAA
Identifier Type: -
Identifier Source: org_study_id
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