MedTrace Logo

Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome

NCT04358497 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-04-24

No results posted yet for this study

Summary

Compare the efficacy and safety of endovascular treatment with sandwich technique (controlled release coils and 2% polidocanol foam) associated with diosmin-hisperidine and ibuprofen medical treatment and only the best chronic medical treatment available diosmin-hisperidine and ibuprofen for 3 months, in women of active gynecological age carrying pelvic congestion syndrome in public assistance in Montevideo, Uruguay.

Conditions

  • Pelvic Congestive Syndrome
  • Pelvic Varices
  • Venous Disease

Interventions

DEVICE

Medtronic® Concerto® detachable coil system

coil embolization of the reflux pathways

PROCEDURE

sclerosis

Pelvic varices sclerosis with polidocanol foam

DRUG

Diosmin / Hesperidin

Best chronic medial treatment

DRUG

Ibuprofen 400 mg

NSAID treatment

Sponsors & Collaborators

  • University of the Republic, Uruguay

    collaborator OTHER

  • Centro Cardiovascular Universitario

    collaborator UNKNOWN

  • Centro Hospitalario Pereyra Rossell

    collaborator UNKNOWN

  • Hospital de Clínicas Dr. Manuel Quintela

    lead OTHER

Principal Investigators

  • Sebastian Sarutte, VS · Centro Cardiovascular Universitario

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-07-31
Completion
2022-10-01
FDA Drug
Yes
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04358497 on ClinicalTrials.gov