Status:
COMPLETED
Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome
Lead Sponsor:
Group of Research in Minimally Invasive Techniques
Conditions:
Pelvic Congestion Syndrome
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
This prospective randomized study compares the safety and efficacy of two different embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils and vascular plugs.
Detailed Description
This prospective randomized study compares the safety and efficacy of two embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils (Nester coils; Cook Medical) and vas...
Eligibility Criteria
Inclusion
- Signed informed consent
- Presence of chronic abdominal or pelvic pain for more than 6 months
- \>6 mm pelvic venous caliber measured by transvaginal US
- Presence of venous reflux OR presence of communicating veins assessed by transvaginal Doppler US
Exclusion
- Diagnosed gynecological or pelvic pathology: endometriosis, pelvic inflammatory disease, postoperative adhesions, adenomyosis or leiomyoma
- Glomerular filtration rate \<60 ml/min
- History of contrast reaction
- Patients not able to be followed up for at least one year
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02796092
Start Date
February 1 2014
End Date
April 1 2016
Last Update
March 29 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lozano Blesa University Hospital
Zaragoza, Zaragoza, Spain, 50003