Ignite Creation Date:
2024-05-06 @ 2:54 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04461860
Status:
UNKNOWN
Last Update Posted:
2020-07-08
First Post:
2020-06-19
Brief Title:
Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization SCVPC
Status:
UNKNOWN
Status Verified Date:
2020-05
Last Known Status:
RECRUITING
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:
SCVPC
Brief Summary:
Summary
Main Objective to evaluate the efficacy of pelvic gonadal vein embolization with coils in treatment of pelvic congestion syndrome Methods retrospective study included 25 patients in the University hospital of Brest
The Primary Outcome Measure To evaluate to measure pain relief using visual analogous scale VAS before and after gonadal vein embolization for pelvic congestion syndrome The Secondary Outcome Measures were to assess the impact of the treatment on specific and general symptoms through a survey
Main Objective to evaluate the efficacy of pelvic gonadal vein embolization with coils in treatment of pelvic congestion syndrome Methods retrospective study included 25 patients in the University hospital of Brest
The Primary Outcome Measure To evaluate to measure pain relief using visual analogous scale VAS before and after gonadal vein embolization for pelvic congestion syndrome The Secondary Outcome Measures were to assess the impact of the treatment on specific and general symptoms through a survey
Detailed Description:
A retrospective non-invasive monocentric study of our Hospital 10-year registry including data on MRI angiography and Vascular Doppler Ultrasound of patients who have already undergone coil embolization of pelvic gonadal vein in treatment of pelvic congestion syndrome These patients will be contacted by phone to participate in the study An information letter will be handed out and the study protocol will be explained to the patients After obtaining their written consent they will be asked to fill out the studys validated questionnaire at home and return it to us through pre-paid regular mail A face to face interview with the patient will be scheduled to assess the correlation between patients clinical symptoms and survey results There will be no change in patients routine follow-up care
All physician investigators of the study are experts in their field of medicine eg interventional MRI angiography vascular disease
All physician investigators of the study are experts in their field of medicine eg interventional MRI angiography vascular disease
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?:
None
Is an FDA AA801 Violation?:
None