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

NCT07221695 | Enrolling By Invitation FDA Device

• 1 other identifier: glue vs coil for ovarian ttt
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pelvic Congestive Syndrome

Outcome Measures

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

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

  18 months

Study Arms (2)

Embolization using polidocanol foam followed by N-butyl cyanoacrylate

ACTIVE COMPARATOR

. After selective catheterization of the ovarian vein and reflux confirmation, Sclerosant foam will be prepared using 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. The foam will be injected slowly into the reservoir of the refluxing segment of the ovarian vein under fluoroscopic guidance to induce endothelial irritation and reduce venous flow. A total of 5-10 mL of 3% polidocanol foam will be injected per vein, adjusted based on vein diameter and reflux length. Next, N-butyl cyanoacrylate (Gluebran®️ 2) will be mixed with Lipiodol in a 1:2 to 1:3 ratio, depending on vein size and flow rate. Approximately 1-2 mL of the glue mixture will be injected per vein using a coaxial microcatheter system from distal to proximal segments. Occlusion will be confirmed by post-embolization venography."

Other: Foam + N-butyl Cyanoacrylate

Combined Foam Sclerotherapy and Detachable Coil Embolization

ACTIVE COMPARATOR

Patients in this group will undergo embolization using sclerosant foam followed by detachable platinum coils. Vascular access and catheterization technique will mirror Group A. After injecting polidocanol foam (as above), subsequently, detachable platinum fibered coils - specifically Interlock™ (Boston Scientific) or Concerto™ (Medtronic) - will be deployed to achieve permanent mechanical occlusion. Coil selection (diameter and length) will be based on intra-procedural vein sizing. Final occlusion will be confirmed via completion venography.

Other: Combined Foam Sclerotherapy and Detachable Coil Embolization

Interventions

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.

Embolization using polidocanol foam followed by N-butyl cyanoacrylate

Combined Foam Sclerotherapy and Detachable Coil Embolization OTHER

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

Combined Foam Sclerotherapy and Detachable Coil Embolization

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr El Shaykh University

Kafr ash Shaykh, Kafrelshaykh Governorate, 33511, Egypt

Location

MeSH Terms

Interventions

Enbucrilate

Intervention Hierarchy (Ancestors)

Cyanoacrylates; Acrylates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitriles; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Tissue Adhesives; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 12, 2025
• First Posted: October 28, 2025
• Study Start: August 25, 2025
• Primary Completion: August 25, 2025
• Study Completion: December 25, 2025
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)