Embolization Strategies for Pelvic Venous Disorders: Foam + Glue vs Foam + Coils (NCT07221695) | Clinical Trial Compass
By InvitationNot Applicable
Embolization Strategies for Pelvic Venous Disorders: Foam + Glue vs Foam + Coils
Egypt60 participantsStarted 2025-08-25
Plain-language summary
Foam Plus Glue Versus Foam Plus Coils for Ovarian Vein Embolization in the Treatment of Pelvic Venous Disorders: A Randomized Controlled Trial
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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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…
What they're measuring
1
compare the clinical efficacy of ovarian vein embolization using combined foam plus N-butyl cyanoacrylate (Gluebran®️) versus combined foam plus detachable coils