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

Pelvic Varicose Veins Treated With Vascular Plugs Type Amplatzer: REPiVAC

Sponsors

Lead sponsor: Group of Research in Minimally Invasive Techniques

Source 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

Overall Status Recruiting
Start Date March 1, 2019
Completion Date January 1, 2021
Primary Completion Date November 1, 2019
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Embolization of pelvic varicose veins using AVP 24 months
Enrollment 300
Condition
Intervention

Intervention type: Device

Intervention name: pelvic varicose veins plug embolization

Description: pelvic varicose veins plug embolization

Arm group label: Women with pelvic congestion syndrome

Eligibility

Sampling method: Probability Sample

Criteria:

Inclusion Criteria:

- Female < 18 years

- Present symptomatology

- At least one image diagnosis

Exclusion Criteria:

- Female > 18

- Non present symptomatology

- Non diagnosis

Gender: Female

Gender based: Yes

Gender description: Women older than 18, minimun 1 bith

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Miguel A De Gregorio, Ph.D. Principal Investigator Minimal Invasive Techniques Research Group
Overall Contact

Last name: Miguel A De Gregorio, Ph.D.

Phone: +34976765768

Email: [email protected]

Location
facility status contact
Lozano Blesa Universitary Hospital | Zaragoza, Aragon, 50009, Spain Recruiting Miguel Angel De Gregorio, Phd 34976765768 [email protected]
Hospital Vithas Nisa Pardo de Aravaca | Madrid, 28023, Spain Recruiting Jose Urbano, M.D 34 915 12 90 00 [email protected]
Location Countries

Spain

Verification Date

October 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Women with pelvic congestion syndrome

Description: Women older than 18 years At least 1 birth Present symptoms

Acronym REPiVAC
Patient Data No
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov