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

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ClinicalTrials.gov Identifier: NCT04115137
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pelvic Congestion Syndrome Pelvic Varicose Veins Follow-up Study Embolization, Therapeutic Observational Study 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


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Multicentric Spanish Record of Pelvic Varicose Veins Treated With Vascular Plugs Type Amplatzer - Pelvic Congestion Syndrome: Study of Efficacy and Safety
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

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




Primary Outcome Measures :
  1. Embolization of pelvic varicose veins using AVP [ Time Frame: 24 months ]
    39/5000 absence of symptoms and vaginal ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women older than 18, minimun 1 bith
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women older than 18 years , minimun 1 bith and with symptoms of pelvic congestion syndrome
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Female > 18
  • Non present symptomatology
  • Non diagnosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115137


Contacts
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Contact: Miguel A De Gregorio, Ph.D. +34976765768 mgregori@unizar.es
Contact: José A Guirola, M.D. +34976556400 ext 162984 joseandresguirola@gmail.com

Locations
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Spain
Lozano Blesa Universitary Hospital Recruiting
Zaragoza, Aragon, Spain, 50009
Contact: Miguel Angel De Gregorio, Phd    34976765768    mgregori@unizar.es   
Hospital Vithas Nisa Pardo de Aravaca Recruiting
Madrid, Spain, 28023
Contact: Jose Urbano, M.D    34 915 12 90 00    jurbano34@gmail.com   
Sponsors and Collaborators
Group of Research in Minimally Invasive Techniques
Investigators
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Principal Investigator: Miguel A De Gregorio, Ph.D. Minimal Invasive Techniques Research Group

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Responsible Party: Group of Research in Minimally Invasive Techniques
ClinicalTrials.gov Identifier: NCT04115137     History of Changes
Other Study ID Numbers: GITMI-05
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Group of Research in Minimally Invasive Techniques:
Pelvic Congestion Syndrome
amplatzer vascular plug
Vascular plug
metallic embolization device
Chronic pelvic pain
embolization procedure
Additional relevant MeSH terms:
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Varicose Veins
Syndrome
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases