Pelvic Varicose Veins Treated With Vascular Plugs Type Amplatzer: REPiVAC

Observational Study Clinical Trial

— REPiVAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04115137
• Other study ID #: GITMI-05
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: October 2019
• Source: Group of Research in Minimally Invasive Techniques
• Contact: Miguel A De Gregorio, Ph.D.
• Phone: +34976765768
• Email: mgregori[@]unizar.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 1, 2021
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Female < 18 years

• Present symptomatology

• At least one image diagnosis

Exclusion Criteria:

• Female > 18

• Non present symptomatology

• Non diagnosis

Related Conditions & MeSH terms

• Embolization, Therapeutic
• Follow-up Study
• Observational Study
• Pelvic Congestion Syndrome
• Pelvic Varicose Veins
• Syndrome
• Varicose Veins

Intervention

Device:
• pelvic varicose veins plug embolization
pelvic varicose veins plug embolization

Locations

Country	Name	City	State
Spain	Hospital Vithas Nisa Pardo de Aravaca	Madrid
Spain	Lozano Blesa Universitary Hospital	Zaragoza	Aragon

Sponsors (1)

Lead Sponsor	Collaborator
Group of Research in Minimally Invasive Techniques

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Embolization of pelvic varicose veins using AVP	39/5000 absence of symptoms and vaginal ultrasound	24 months