Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-29 @ 1:06 AM
Study NCT ID:
NCT02086435
Status:
COMPLETED
Last Update Posted:
2015-04-21
First Post:
2014-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes
Sponsor:
University Magna Graecia
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial on Intracorporeal Versus Extracorporeal Morcellation With Endobag Extraction in Patients Undergoing Laparoscopic Myomectomy: Clinical Efficacy and Safety Outcomes
Status:
COMPLETED
Status Verified Date:
2015-04
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:
IEME
Brief Summary:
The aim of this study protocol will be to compare the technique of intracorporeal morcellation using reusable electronic device (standard technique) with a technique of removal "protected" by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: