Pelvic Varicose Veins Treated With Vascular Plugs Type Amplatzer: REPiVAC (REPiVAC)

Multicentric Spanish Record of Pelvic Varicose Veins Treated With Vascular Plugs Type Amplatzer - Pelvic Congestion Syndrome: Study of Efficacy and Safety

Spanish multicentric record to study the efficacy and safety of the treatment with plugs in Pelvic Congestion Syndrome.

Study Overview

• Status: Unknown
• Conditions: Observational Study; Pelvic Congestion Syndrome; Embolization, Therapeutic; Pelvic Varicose Veins; Follow-up Study
• Intervention / Treatment: Device: pelvic varicose veins plug embolization

Detailed Description

This is an prospective observational study of patients that have been treated with plugs (type Amplazer) at least one of the pelvic varicose veins.

Patients are recruited when the plug is implanted, and the investigators perfom a patients follow-up during 1, 3, 6, 12, 24 months

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Miguel A De Gregorio, Ph.D.; Phone Number: +34976765768; Email: mgregori@unizar.es
• Study Contact Backup: Name: José A Guirola, M.D.; Phone Number: 162984 +34976556400; Email: joseandresguirola@gmail.com

Study Locations

• Spain
  • Madrid, Spain, 28023
    • Recruiting
    • Hospital Vithas Nisa Pardo de Aravaca
    • Contact: Jose Urbano, M.D; Phone Number: 34 915 12 90 00; Email: jurbano34@gmail.com
  • Aragon
    • Zaragoza, Aragon, Spain, 50009
      • Recruiting
      • Lozano Blesa Universitary Hospital
      • Contact: Miguel Angel De Gregorio, Phd; Phone Number: 34976765768; Email: mgregori@unizar.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women older than 18 years , minimun 1 bith and with symptoms of pelvic congestion syndrome

Description

Inclusion Criteria:

• Female < 18 years
• Present symptomatology
• At least one image diagnosis

Exclusion Criteria:

• Female > 18
• Non present symptomatology
• Non diagnosis

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with pelvic congestion syndrome; Women older than 18 years At least 1 birth Present symptoms	Device: pelvic varicose veins plug embolization; pelvic varicose veins plug embolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Embolization of pelvic varicose veins using AVP	39/5000 absence of symptoms and vaginal ultrasound	24 months

Collaborators and Investigators

• Sponsor: Group of Research in Minimally Invasive Techniques
• Investigators: Principal Investigator: Miguel A De Gregorio, Ph.D., Minimal Invasive Techniques Research Group

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ANTICIPATED): November 1, 2019
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (ACTUAL): October 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Chronic pelvic pain; Pelvic Congestion Syndrome; amplatzer vascular plug; Vascular plug; metallic embolization device; embolization procedure
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Varicose Veins
• Other Study ID Numbers: GITMI-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No