Embolization of Pelvic Veins in Treatment of Pelvic Congestion Syndrome

NCT ID: NCT03165214

Last Updated: 2020-08-12

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-09-30

Brief Summary

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Chronic pelvic pain is defined as chronic or persistent pain perceived in structures related to the pelvis of either men or women for more than 6 months according to The International Association for the Study of Pain. In other words, chronic pelvic pain with associated ovarian vein varicosities is termed pelvic congestion syndrome and is an important but under-diagnosed condition

Detailed Description

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Conditions

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Pelvic Congestive Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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coil group

micro coils

Group Type ACTIVE_COMPARATOR

coil

Intervention Type DEVICE

microcoils

glue group

hystoacryl mixed with lipidol

Group Type EXPERIMENTAL

hystoacryl glue

Intervention Type DEVICE

hystoacryl mixed with lipidol

Interventions

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coil

microcoils

Intervention Type DEVICE

hystoacryl glue

hystoacryl mixed with lipidol

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Clinical symptoms of pelvic congestion syndrome documented by Doppler ultrasound
* Failed medical treatment.

Exclusion Criteria

* Endometriosis.
* Uterine fibroids.
* Previous pelvic operations.
* Urological diseases.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Site Status

Assiut Faculty of Medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PCS

Identifier Type: -

Identifier Source: org_study_id

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