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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
10 participants
INTERVENTIONAL
2021-01-31
2021-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Hysteroscopic morcellation had been used for intrauterine tissue extraction for over 20 years. Hysteroscopic morcellators have been shown to provide 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 removal for 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.
A feasibility study conducted in our institute showed that the use of the hysteroscopic morcellator for resection of the fetal tissue in early missed abortions is feasible and safe and 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 prior to our study in only one case published in the literature and was found to be feasible, although the authors state that visibility was poor while resecting the implantation site due to high vascularization.
After demonstrating that hysteroscopic morcellation is possible in cases of early missed abortions, we suggest that the procedure will be possible and safe in cases of early induced abortions, with similar potential benefits.
In this pilot feasibility study, we hypothesize that the Truclear Elite tissue removal 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.
This study is a prospective trial. All patients reffered for induced abortion by dilatation and curettage with a gestational age of under 9 weeks in Assuta Ashdod University Hospital that fit the inclusion criteria will be offered to participate.
Two hours prior to the procedure, patients without contraindications can receive cervical preparation with misoprostol 400mcg sublingual.
In theatre under general anesthesia The cervix can be dilated up to an 8 Hegar. Embryoscopy with the TRUCLEAR Elite hysteroscopic morcellation system will be performed and findings will be recorded on a video and in the data collection sheet. The location of the pregnancy, size and specific embryonic findings will be documented.
Following embryoscopy the system will be activated, and the products of conception will be aspirated. If significant bleeding will obscure the hysteroscopic image, vasopressin can be used. 20 units of vasopressin will be diluted in 100ml of saline and injected into the cervix at four and eight o'clock.
The procedure will be performed under abdominal ultrasound guidance to minimize the possibility of perforation. If visibility will be too poor, the procedure will be abandoned and routine suction curettage will be performed using the abdominal ultrasound for guidance All patients will receive prophylactic antibiotics with doxycycline and a follow up appointment with an us examination will be scheduled 2-4 weeks following the procedure and a routine diagnostic hysteroscopy will also be offered 4-6 weeks following the procedure.
Patients will be recruited from the population of patients referred for dilatation and curettage at Assuta Ashdod University Hospital for induced abortion. The researcher will inform the patient about the study. The purpose of the study and possible complications, advantages and alternatives. Patients will not be cajoled into participating in this study. The Investigator will discuss foreseeable risks involved, as well as potential benefits. Patients who have consented to having their information obtained during the study for analysis of the results will have their confidentiality maintained at all times using a study code as an identifier. The patients will be informed by the Investigator that it is their choice to participate and if they do not participate their medical treatment will not be jeopardized. If the patient chooses to participate, they may withdraw from the study at any time without compromising further medical care. A signed and dated Informed Consent must be obtained by the Investigator from the patient prior to enrolment into this study. The original signed and dated information sheet and patient consent will be kept by the Investigator. A signed copy will be provided to the patient.
Since this is a pilot study designed to test the feasibility of the procedure the sample size will include 10 women. This will allow accurate assessment of the procedure and possible issues that might be related to the procedure.
Data collection plan:
1. Pre-procedural: Age, Ethnicity, Weight, Height, Smoking, Medical, Gynecological and Surgical History, Previous hysteroscopies, Previous D\&C. Ultrasound scanning findings, LMP.
2. During hysteroscopy: Findings (video recording of procedure), Blood loss, Volume deficit, Length of procedure, Vision, The need to resort to other methods such as D\&C, US (ultrasound) findings at the end of the procedure, complications, US during the procedure (recording)
3. Post-procedure: Surgical complications, Hysteroscopy success and post operative course (time to discharge), Findings on follow up examination and US in 2-4 weeks, Findings on follow up diagnostic hysteroscopy in 4-6 weeks.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Interventional arm
Single arm, no comparison
Hysteroscopic Embryolysis
Hysteroscopic removal of the products of conception for induced abortion using a hysteroscopic morcellator. If this method of induced abortion fails, a traditional Dilation and Curettage procedure is performed
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hysteroscopic Embryolysis
Hysteroscopic removal of the products of conception for induced abortion using a hysteroscopic morcellator. If this method of induced abortion fails, a traditional Dilation and Curettage procedure is performed
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Referred for dilatation and curettage for induced abortion
3. Confirmed intrauterine pregnancy with gestational age of up to 9 weeks
4. At least one previous normal vaginal delivery with a healthy child
5. Patients are able to provide written consent
6. Patients with no underlying medical conditions
Exclusion Criteria
2. Significant uterine bleeding, fever or incomplete abortion
3. Previous cesarean section
4. Sub-chorionic hematoma, Malformed uterus or Submucosal fibroids
5. Any underlying medical condition requiring medical treatment
6. Documented failed hysteroscopy prior to the current referral
21 Years
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Oshri Barell
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Oshri Barell
Head of Gynecology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Oshri Barel, MD
Role: PRINCIPAL_INVESTIGATOR
Assuta Ashdod Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Assuta Ashdod University Hospital
Ashdod, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0206-20-AAA
Identifier Type: -
Identifier Source: org_study_id