Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT06168058
Eligibility Criteria:
Inclusion Criteria:
1. Presence of venous origin chronic pelvic pain for greater than 6 months (VAS ≥7 as determined by 4 consecutive weeks of baseline self-assessments) despite non-vascular therapy as delineated by the following criteria:
* Pain exacerbated by walking, standing or lifting
* Symptoms are at least partially alleviated by lying down
* Prolonged post-coital ache
* Absence of non-venous origin CPP as determined by Gynecology examination
2. Symptoms-Varices-Pathophysiology Classification18 including of one of the following:
•S2V2PBGV,R,NT, S2V2PRGV,R,NT , S2V2PLGV,R,NT, with or without S2V2 PBIIV,R,NT, S2V2 PLIIV,R,NT, S2V2 PRIIV,R,NT
3. CT, TAUS and diagnostic venography (if needed) imaging review for pelvic venous imaging factors
* Left or right ovarian vein diameter greater than or equal to 6 mm as documented by TAUS or CT
* Presence of intrabdominal/pelvic varices as documented by TAUS or CT (≥1 veins, \>5 mm diameter)
* Presence of venous reflux in ovarian and/or internal iliac veins without evidence of hemodynamically significant stenosis
Exclusion Criteria:
* Female \<18 years of age
* Pregnancy (positive pregnancy test)
* Female subject who plans to become pregnant during study period
* Female subject who is actively breastfeeding
* Patient who is post-menopausal or anovulatory with hormone suppression
* History of prior hysterectomy
* Prior ovarian vein embolization or ovarian vein ligation
* Inability to tolerate endovascular procedure due to acute illness or general health
* Planned simultaneous treatment with nerve blocks during the duration of the study
* Laparoscopy or planned surgical intervention during the duration of the study
* Known allergy to sclerosant, coil, stent or catheter components including nickel allergy
* Any iliac vein stenosis determined identified by the investigator on pelvic DUS, CT venogram, and/or Catheter Venography and deemed significant for exclusion by study patient review committee.
* Any renal vein stenosis with resultant renal hilar varices/collaterals and lumbar collaterals identified by the investigator on pelvic DUS, CT venogram, and/or Diagnostic Venography and deemed significant for exclusion by study patient review committee.
* Presence of isolated extra-pelvic vulvar and/or lower extremity varices without intrabdominal pelvic varices. Primary S3 categorization study exclusion.
* Serious medical conditions that might preclude full participation in the study to the desired endpoint (e.g., uncontrolled diabetes, malignancy, COPD, MI, CHF, etc.)
* Severe allergy to iodinated or gadolinium-based contrast refractory to steroid premedication
* Severe renal impairment (on chronic dialysis or estimated GFR \<30 mL/min)
* Hemoglobin \<8.0 g/dL, uncorrectable INR \>3.0 or platelet count \<75,000/microliter
* Inability to provide informed consent or to comply with study assessments
* Post thrombotic IVC, iliac or ovarian vein changes
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06168058
Study Brief:
Protocol Section:
NCT06168058