Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome

Group of Research in Minimally Invasive Techniques

Status: Completed

Conditions: Pelvic Congestion Syndrome

Treatments: Device: Fibered platinum coils; Device: Vascular plugs

Study type: Interventional

Funder types: Other

Identifiers

NCT02796092

GTM-01

Details and patient eligibility

About

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.

Full 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 vascular plugs (Amplatzer vascular plugs II; St. Jude Medical).

Enrollment: 100 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Fibered platinum coils

Active Comparator group

Description:

Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)

Treatment:

Device: Fibered platinum coils

Vascular plugs

Experimental group

Description:

Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)

Treatment:

Device: Vascular plugs