Study Stopped
No patients recruited
Embolization of Pelvic Veins in Treatment of Pelvic Congestion Syndrome
Effectiveness of Embolization of Pelvic Veins in Treatment of Pelvic Congestion Syndrome
1 other identifier
interventional
N/A
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2017
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2017
CompletedFirst Posted
Study publicly available on registry
May 24, 2017
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedAugust 12, 2020
August 1, 2020
2 years
May 23, 2017
August 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The number of treated patients with different interventions
6 months
Study Arms (2)
coil group
ACTIVE COMPARATORmicro coils
glue group
EXPERIMENTALhystoacryl mixed with lipidol
Interventions
Eligibility Criteria
You may qualify if:
- Clinical symptoms of pelvic congestion syndrome documented by Doppler ultrasound
- Failed medical treatment.
You may not qualify if:
- Endometriosis.
- Uterine fibroids.
- Previous pelvic operations.
- Urological diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ahmed Abbas
Assiut, Cairo Governorate, 002, Egypt
Assiut Faculty of Medicine
Asyut, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
May 23, 2017
First Posted
May 24, 2017
Study Start
July 1, 2017
Primary Completion
July 1, 2019
Study Completion
September 1, 2019
Last Updated
August 12, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share