Pelvic Varicose Veins Treated With Vascular Plugs Type Amplatzer: REPiVAC

• Conditions: Follow-up Study; Observational Study; Pelvic Varicose Veins; Pelvic Congestion Syndrome; Embolization, Therapeutic
• Interventions: Device: pelvic varicose veins plug embolization

• Registration Number: NCT04115137
• Lead Sponsor: Group of Research in Minimally Invasive Techniques

Brief Summary

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

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 Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-07-11
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-02
• Last Update Submitted: 2019-10-02
• Study First Posted: 2019-10-03
• Last Update Posted: 2019-10-03
• Primary Completion: 2019-11-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• Female > 18
• Non present symptomatology
• Non diagnosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with pelvic congestion syndrome	pelvic varicose veins plug embolization	Women older than 18 years At least 1 birth Present symptoms

Primary Outcome Measures

Name	Time	Method
Embolization of pelvic varicose veins using AVP	24 months	39/5000 absence of symptoms and vaginal ultrasound

Trial Locations

Locations (2)

Lozano Blesa Universitary Hospital; 🇪🇸 Zaragoza, Aragon, Spain

Hospital Vithas Nisa Pardo de Aravaca; 🇪🇸 Madrid, Spain