Back to resultsEmbolization of Pelvic Veins in Treatment of Pelvic Congestion Syndrome
Primary Purpose
Pelvic Congestive Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
coil
hystoacryl glue
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Congestive Syndrome
Eligibility Criteria
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.
Sites / Locations
- Ahmed Abbas
- Assiut Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
coil group
glue group
Arm Description
micro coils
hystoacryl mixed with lipidol
Outcomes
Primary Outcome Measures
The number of treated patients with different interventions
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03165214
Brief Title
Embolization of Pelvic Veins in Treatment of Pelvic Congestion Syndrome
Official Title
Effectiveness of Embolization of Pelvic Veins in Treatment of Pelvic Congestion Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No patients recruited
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Congestive Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
coil group
Arm Type
Active Comparator
Arm Description
micro coils
Arm Title
glue group
Arm Type
Experimental
Arm Description
hystoacryl mixed with lipidol
Intervention Type
Device
Intervention Name(s)
coil
Intervention Description
microcoils
Intervention Type
Device
Intervention Name(s)
hystoacryl glue
Intervention Description
hystoacryl mixed with lipidol
Primary Outcome Measure Information:
Title
The number of treated patients with different interventions
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ahmed Abbas
City
Assiut
State/Province
Cairo
ZIP/Postal Code
002
Country
Egypt
Facility Name
Assiut Faculty of Medicine
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Embolization of Pelvic Veins in Treatment of Pelvic Congestion Syndrome
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