Enrolling by invitation NCT07221695
Embolization Strategies for Pelvic Venous Disorders: Foam + Glue vs Foam + Coils
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Foam + N-butyl Cyanoacrylate, Combined Foam Sclerotherapy and Detachable Coil Embolization.
- Who it may be relevant to
- Registry conditions: Pelvic Congestive Syndrome. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Foam Plus Glue Versus Foam Plus Coils for Ovarian Vein Embolization in the Treatment of Pelvic Venous Disorders:
Overview
Foam Plus Glue Versus Foam Plus Coils for Ovarian Vein Embolization in the Treatment of Pelvic Venous Disorders: A Randomized Controlled Trial
Interventions
- Other Foam + N-butyl Cyanoacrylate
3% polidocanol (Aethoxysklerol®, Kreussler Pharma), mixed with room air in a 1:4 ratio (1 mL polidocanol to 4 mL air) using the Tessari double-syringe technique, creating a dense and stable foam. - Other Combined Foam Sclerotherapy and Detachable Coil Embolization
polidocanol foam (as above), subsequently, detachable platinum fibered coils - specifically Interlock™ (Boston Scientific) or Concerto™ (Medtronic)
Primary outcome measures
- compare the clinical efficacy of ovarian vein embolization using combined foam plus N-butyl cyanoacrylate (Gluebran®️) versus combined foam plus detachable coils [Time frame: 18 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Kafr El Shaykh University — Kafr ash Shaykh
Identifiers
NCT: NCT07221695 · glue vs coil for ovarian ttt