Recruiting

Gonadal Vein Embolization

Sponsor:

University of Kansas Medical Center

Code:

NCT03794466

Conditions

Pelvic Congestive Syndrome

Pelvic Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Pelvic Congestive Syndrome

Pelvic Pain

Study ID

NCT03794466

Start date

May 10, 2019

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Quantify pain relief using the Pelvic Congestion Symptom Pain Scale after gonadal vein embolization [ Time Frame: Change from baseline (before gonadal vein embolization) to 360 days post-procedure. ]

Central Contacts and Locations

Central contacts

Carissa Walter, MPH

9139457450cwalter2@kumc.edu

Locations

The University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Carissa Walter, MPH

913-945-7450cwalter2@kumc.edu

Principal Investigator:

Adam S Alli, MD

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • gonadal vein embolization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-03-23.