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

NCT ID: NCT02796092

Last Updated: 2017-03-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-04-30

Brief Summary

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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

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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).

Conditions

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Pelvic Congestion Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Fibered platinum coils

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

Group Type ACTIVE_COMPARATOR

Fibered platinum coils

Intervention Type DEVICE

Vascular plugs

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

Group Type EXPERIMENTAL

Vascular plugs

Intervention Type DEVICE

Interventions

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Fibered platinum coils

Intervention Type DEVICE

Vascular plugs

Intervention Type DEVICE

Other Intervention Names

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Nester coils Amplatzer vascular plugs

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Group of Research in Minimally Invasive Techniques

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miguel A De Gregorio, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Zaragoza

Locations

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Lozano Blesa University Hospital

Zaragoza, Zaragoza, Spain

Site Status

Countries

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Spain

Other Identifiers

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GTM-01

Identifier Type: -

Identifier Source: org_study_id

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