Pelvic Varicose Veins Treated With Vascular Plugs Type Amplatzer: REPiVAC

NCT ID: NCT04115137

Last Updated: 2019-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-01-01

Brief Summary

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

Detailed Description

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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

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with pelvic congestion syndrome

Women older than 18 years At least 1 birth Present symptoms

pelvic varicose veins plug embolization

Intervention Type DEVICE

pelvic varicose veins plug embolization

Interventions

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pelvic varicose veins plug embolization

pelvic varicose veins plug embolization

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female \< 18 years
* Present symptomatology
* At least one image diagnosis

Exclusion Criteria

* Female \> 18
* Non present symptomatology
* Non diagnosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Group of Research in Minimally Invasive Techniques

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miguel A De Gregorio, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Minimal Invasive Techniques Research Group

Locations

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Lozano Blesa Universitary Hospital

Zaragoza, Aragon, Spain

Site Status RECRUITING

Hospital Vithas Nisa Pardo de Aravaca

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Miguel A De Gregorio, Ph.D.

Role: CONTACT

+34976765768

José A Guirola, M.D.

Role: CONTACT

+34976556400 ext. 162984

Facility Contacts

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Miguel Angel De Gregorio, Phd

Role: primary

34976765768

Jose Urbano, M.D

Role: primary

34 915 12 90 00

Other Identifiers

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GITMI-05

Identifier Type: -

Identifier Source: org_study_id

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