NCT04115137

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

July 11, 2019

Last Update Submit

October 2, 2019

Conditions

Pelvic Congestion SyndromePelvic Varicose VeinsFollow-up StudyEmbolization, TherapeuticObservational Study

Keywords

Pelvic Congestion Syndromeamplatzer vascular plugVascular plugmetallic embolization deviceChronic pelvic painembolization procedure

Outcome Measures

Primary Outcomes (1)

  • Embolization of pelvic varicose veins using AVP

    39/5000 absence of symptoms and vaginal ultrasound

    24 months

Study Arms (1)

Women with pelvic congestion syndrome

Women older than 18 years At least 1 birth Present symptoms

Device: pelvic varicose veins plug embolization

Interventions

pelvic varicose veins plug embolizationDEVICE

pelvic varicose veins plug embolization

Women with pelvic congestion syndrome

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen older than 18, minimun 1 bith
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women older than 18 years , minimun 1 bith and with symptoms of pelvic congestion syndrome

You may qualify if:

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

You may not qualify if:

  • Female \> 18
  • Non present symptomatology
  • Non diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lozano Blesa Universitary Hospital

Zaragoza, Aragon, 50009, Spain

RECRUITING

Hospital Vithas Nisa Pardo de Aravaca

Madrid, 28023, Spain

RECRUITING

Study Officials

  • Miguel A De Gregorio, Ph.D.

    Minimal Invasive Techniques Research Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel A De Gregorio, Ph.D.

CONTACT

+34976765768mgregori@unizar.es

José A Guirola, M.D.

CONTACT

+34976556400joseandresguirola@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2019

First Posted

October 3, 2019

Study Start

March 1, 2019

Primary Completion

November 1, 2019

Study Completion

January 1, 2021

Last Updated

October 3, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)