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 @ 1:21 PM
Ignite Modification Date:
2025-12-24 @ 1:21 PM
NCT ID:
NCT07221695
Eligibility Criteria:
Inclusion Criteria
* Female patients aged 18 to 50 years
* Clinically suspected pelvic venous disorder (PVD), presenting with chronic pelvic pain ≥ 6 months
* Pelvic pain intensity ≥ 4 on a 10-point Visual Analogue Scale (VAS) at baseline
* No evidence of significant venous obstruction or internal iliac insufficiency
* Willingness to participate, provide written informed consent, and comply with study visits and procedures exclusion criteria
* Pregnancy or planning to conceive within the next 12 months
* Significant Nutcracker syndrome diagnosed by duplex / CTV / MRV
* Significant May-Thurner syndrome diagnosed by duplex / CTV / MRV
* Non-ovarian sources of reflux requiring intervention, including internal iliac vein insufficiency; During venography all patients will undergo selective pelvic venography prior embolization to exclude patients who have combined gonadal and internal iliac vein reflux)
* History of previous pelvic vein embolization or surgical ligation
* Coagulopathy, defined as:
* INR \> 1.5
* Platelet count \< 50 × 10⁹/L
* Severe comorbidities, including:
* Active pelvic infection (e.g., pelvic inflammatory disease)
* End-stage renal disease (eGFR \< 30 mL/min/1.73 m²)
* Decompensated heart failure (NYHA class III-IV)
* Active malignancy requiring treatment
Known allergy or hypersensitivity to:
* Iodinated contrast media
* Polidocanol (Aethoxysklerol®)
* N-butyl cyanoacrylate (e.g., Gluebran® 2)
* Nickel, platinum, or stainless steel (components of embolization coils) . Presence of non-venous pelvic pathology requiring immediate management
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07221695
Study Brief:
Protocol Section:
NCT07221695