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

NCT02796092 | Completed Results DMC

• 1 other identifier: GTM-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Congestion Syndrome

Keywords

Pelvic Congestion Syndrome; Pelvic Venous Insufficiency; Chronic pelvic pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Scale

  Reduction of 4 points or more between subjective pain assessed by VAS prior to procedure (-4, -5,- 6, -7,-8,-9). VAS= visual analogue scale: it is a subjective pain scale, scored from 1 to 10 (1 no pain; 10 worst pain possible)

  12 months

Secondary Outcomes (13)

• Improvement of Dyspareunia

  12 months

• Improvement of Urinary Urgency

  12 months

• Improvement of Dysmenorrhea

  12 months

• Satisfaction With the Procedure

  12 months

• Number of Devices Used

  intraoperative

Study Arms (2)

Fibered platinum coils

ACTIVE COMPARATOR

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

Device: Fibered platinum coils

Vascular plugs

EXPERIMENTAL

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

Device: Vascular plugs

Interventions

Fibered platinum coils DEVICE

Also known as: Nester coils

Fibered platinum coils

Vascular plugs DEVICE

Also known as: Amplatzer vascular plugs

Vascular plugs

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Group of Research in Minimally Invasive Techniques: lead

Study Sites (1)

Lozano Blesa University Hospital

Zaragoza, Zaragoza, 50003, Spain

Location

Limitations and Caveats

Analysis of cost dependent on the hospital/region/country. It cannot be extrapolated. Small number of subjects to compare complication rate of both techniques.

Results Point of Contact

• Title: Prof. Alicia Laborda
• Organization: GITMI (University of Zaragoza)

alaborda@unizar.es

0034 976 76 15 49

Study Officials

• Miguel A De Gregorio, MD, PhD

  Universidad de Zaragoza

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 10, 2016
• Study Start: February 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: April 1, 2016
• Last Updated: March 29, 2017
• Results First Posted: October 26, 2016

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)