Quantify the Degree of Pain Relief of Pelvic Congestion Syndrome Following Gonadal Vein Embolization
NCT ID: NCT03794466
Last Updated: 2025-04-15
Study Results
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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RECRUITING
30 participants
OBSERVATIONAL
2019-05-10
2025-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Meet the clinical and imaging criteria for the diagnosis of PCS and have no contraindications to coil embolization of the gonadal veins.
* Patients who are treated with coil embolization of the gonadal veins in the Interventional Radiology division between October 1, 2018 to October 1, 2019.
Exclusion Criteria
* Patients who are found to have an underlying cause of pelvic congestion syndrome unrelated to venous congestion and insufficiency. This includes, but is not limited to, nutcracker syndrome, or a mass resulting in extrinsic compression of the gonadal veins.
* Patients who have received prior surgical therapy for PCS, including bilateral salpingo-oophorectomy (TAH-BSO), gonadal vein resection, or gonadal vein ligation.
18 Years
FEMALE
No
Sponsors
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University of Kansas Medical Center
OTHER
Responsible Party
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Principal Investigators
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Adam S Alli, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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The University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Ignacio EA, Dua R, Sarin S, Harper AS, Yim D, Mathur V, Venbrux AC. Pelvic congestion syndrome: diagnosis and treatment. Semin Intervent Radiol. 2008 Dec;25(4):361-8. doi: 10.1055/s-0028-1102998.
O'Brien MT, Gillespie DL. Diagnosis and treatment of the pelvic congestion syndrome. J Vasc Surg Venous Lymphat Disord. 2015 Jan;3(1):96-106. doi: 10.1016/j.jvsv.2014.05.007. Epub 2014 Jun 25.
Koo S, Fan CM. Pelvic congestion syndrome and pelvic varicosities. Tech Vasc Interv Radiol. 2014 Jun;17(2):90-5. doi: 10.1053/j.tvir.2014.02.005.
Lopez AJ. Female Pelvic Vein Embolization: Indications, Techniques, and Outcomes. Cardiovasc Intervent Radiol. 2015 Aug;38(4):806-20. doi: 10.1007/s00270-015-1074-7. Epub 2015 Mar 25.
Daniels JP, Champaneria R, Shah L, Gupta JK, Birch J, Moss JG. Effectiveness of Embolization or Sclerotherapy of Pelvic Veins for Reducing Chronic Pelvic Pain: A Systematic Review. J Vasc Interv Radiol. 2016 Oct;27(10):1478-1486.e8. doi: 10.1016/j.jvir.2016.04.016. Epub 2016 Jul 7.
Brown CL, Rizer M, Alexander R, Sharpe EE 3rd, Rochon PJ. Pelvic Congestion Syndrome: Systematic Review of Treatment Success. Semin Intervent Radiol. 2018 Mar;35(1):35-40. doi: 10.1055/s-0038-1636519. Epub 2018 Apr 5.
Guirola JA, Sanchez-Ballestin M, Sierre S, Lahuerta C, Mayoral V, De Gregorio MA. A Randomized Trial of Endovascular Embolization Treatment in Pelvic Congestion Syndrome: Fibered Platinum Coils versus Vascular Plugs with 1-Year Clinical Outcomes. J Vasc Interv Radiol. 2018 Jan;29(1):45-53. doi: 10.1016/j.jvir.2017.09.011. Epub 2017 Nov 22.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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STUDY00143045
Identifier Type: -
Identifier Source: org_study_id
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