Status:
ENROLLING_BY_INVITATION
Embolization Strategies for Pelvic Venous Disorders: Foam + Glue vs Foam + Coils
Lead Sponsor:
Kafrelsheikh University
Conditions:
Pelvic Congestive Syndrome
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
Foam Plus Glue Versus Foam Plus Coils for Ovarian Vein Embolization in the Treatment of Pelvic Venous Disorders: A Randomized Controlled Trial
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 25 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07221695
Start Date
August 25 2025
End Date
December 25 2025
Last Update
October 28 2025
Active Locations (1)
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1
Kafr El Shaykh University
Kafr ash Shaykh, Kafrelshaykh Governorate, Egypt, 33511