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OpenTrials
Enrolling by Invitation

NCT Number: NCT07221695

Embolization Strategies for Pelvic Venous Disorders: Foam + Glue vs Foam + Coils

Foam Plus Glue Versus Foam Plus Coils for Ovarian Vein Embolization in the Treatment of Pelvic Venous Disorders: A Randomized Controlled Trial

Enrolling by Invitation

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kafr El Shaykh University

Kafr ash Shaykh, Kafrelshaykh Governorate, 33511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Foam + N-butyl Cyanoacrylate

Other

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.

Combined Foam Sclerotherapy and Detachable Coil Embolization

Other

polidocanol foam (as above), subsequently, detachable platinum fibered coils - specifically Interlock™ (Boston Scientific) or Concerto™ (Medtronic)

Primary outcomes

  1. 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

    • Symptom severity reduction, assessed by the Pelvic Venous Clinical Severity Score (PVCSS) at baseline, 3, 6, 12, and 18 months.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Foam Plus Glue Versus Foam Plus Coils for Ovarian Vein Embolization in the Treatment of Pelvic Venous Disorders:

Acronym: foam and coil

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2025
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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