Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04512820
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2020-08-11
Brief Title:
Treatment of Missed Miscarriage With TRUCLEAR Tissue Removal System a Feasiblity Study
Sponsor:
Assuta Ashdod Hospital
Organization:
Assuta Ashdod Hospital
Study Overview
Official Title:
Embryoscopic Evacuation of Early Missed Abortion Using the TRUCLEAR Hysteroscopic Morcellator System a Feasibility Study
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 DC for missed abortions ranged between 16 to 21 percent This technique was assessed in one case for a woman with previous Ashremans 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
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 DC for missed abortions ranged between 16 to 21 percent This technique was assessed in one case for a woman with previous Ashremans 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None