Quantify the Degree of Pain Relief of Pelvic Congestion Syndrome Following Gonadal Vein Embolization (NCT03794466) | Clinical Trial Compass
RecruitingNot Applicable
Quantify the Degree of Pain Relief of Pelvic Congestion Syndrome Following Gonadal Vein Embolization
United States30 participantsStarted 2019-05-10
Plain-language summary
The primary objective is to quantify the degree of pain relief in patients undergoing gonadal vein embolization with coils as well as identify clinical or imaging factors that are predictive of a positive response to treatment, or poor response to treatment.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patients 18 years of age or older
* 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 less than 18 years of age.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantify pain relief using the Pelvic Congestion Symptom Pain Scale after gonadal vein embolization
Timeframe: Change from baseline (before gonadal vein embolization) to 360 days post-procedure.