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Pelvic Varicose Veins Treated With Vascular Plugs Type Amplatzer: REPiVAC

G

Group of Research in Minimally Invasive Techniques

Status

Unknown

Conditions

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

Treatments

Device: pelvic varicose veins plug embolization

Study type

Observational

Funder types

Other

Identifiers

NCT04115137
GITMI-05

Details and patient eligibility

About

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

Full 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

Enrollment

300 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Female > 18
  • Non present symptomatology
  • Non diagnosis

Trial design

300 participants in 1 patient group

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

Trial contacts and locations

2

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Central trial contact

José A Guirola, M.D.; Miguel A De Gregorio, Ph.D.

Data sourced from clinicaltrials.gov

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