Ignite Creation Date:
2025-12-18 @ 8:22 AM
Ignite Modification Date:
2025-12-23 @ 9:58 PM
Study NCT ID:
NCT03123315
Status:
None
Last Update Posted:
2018-02-27 00:00:00
First Post:
2017-04-14 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimization of Ureterolysis During Hysterectomy
Sponsor:
None
Organization:
Study Overview
Official Title:
Optimization of Parameters for Ureterolysis During Minimally Invasive Hysterectomy; Determining Variation in Ureter Position and Degree of Thermal Spread
Status:
None
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
per PI request
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives:
Primary: (While uterus is under tension)
* To determine the shortest distance from the ureter to the uterine vessels.
* To determine the distances from the ureter to the gonadal vessels in infundibulo-pelvic (IP) at the pelvic sidewall. This will be defined at the distance from the IP ligament at the level of the pelvic sidewall to the point on the ureter directly below these vessels
* To determine the distances from the ureter to the gonadal vessels in the infundibulo-pelvic (IP) ligament at the point where the gonadal vessels enter in to the ovary. This will be defined as the distance from where the vessels in the IP enter the ovary to the point on the ureter directly below this.
Secondary
* To determine thermal spread from the Ligasure, and Harmonic device using H\&E and Movat staining.
* To determine the burst pressure of segments of IP ligament that have undergone Ligasure or Harmonic electrosurgery.
Primary: (While uterus is under tension)
* To determine the shortest distance from the ureter to the uterine vessels.
* To determine the distances from the ureter to the gonadal vessels in infundibulo-pelvic (IP) at the pelvic sidewall. This will be defined at the distance from the IP ligament at the level of the pelvic sidewall to the point on the ureter directly below these vessels
* To determine the distances from the ureter to the gonadal vessels in the infundibulo-pelvic (IP) ligament at the point where the gonadal vessels enter in to the ovary. This will be defined as the distance from where the vessels in the IP enter the ovary to the point on the ureter directly below this.
Secondary
* To determine thermal spread from the Ligasure, and Harmonic device using H\&E and Movat staining.
* To determine the burst pressure of segments of IP ligament that have undergone Ligasure or Harmonic electrosurgery.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: