Pelvic Congestive Syndromefoam and coilNCT07221695
Embolization Strategies for Pelvic Venous Disorders: Foam + Glue vs Foam + Coils
A study testing Foam + N-butyl Cyanoacrylate and Combined Foam Sclerotherapy and Detachable Coil Embolization in people with Pelvic Congestive Syndrome, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Foam Plus Glue Versus Foam Plus Coils for Ovarian Vein Embolization in the Treatment of Pelvic Venous Disorders: A Randomized Controlled Trial Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pelvic Congestive Syndrome
- What is being tested?
- Foam + N-butyl Cyanoacrylate and Combined Foam Sclerotherapy and Detachable Coil Embolization
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2025to 25 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 23Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Kafr El Shaykh University
Kafr ash Shaykh, Kafrelshaykh Governorate, 33511
About this study
Official title: Foam Plus Glue Versus Foam Plus Coils for Ovarian Vein Embolization in the Treatment of Pelvic Venous Disorders:
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
- Being tested
- Foam + N-butyl Cyanoacrylate, Combined Foam Sclerotherapy and Detachable Coil Embolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foam + N-butyl CyanoacrylateOther
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 EmbolizationOther
polidocanol foam (as above), subsequently, detachable platinum fibered coils - specifically Interlock™ (Boston Scientific) or Concerto™ (Medtronic)
| Study group | Role | What they receive |
|---|---|---|
| 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." Receives: 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. Receives: Other: Combined Foam Sclerotherapy and Detachable Coil Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the clinical efficacy of ovarian vein embolization using combined foam plus N-butyl cyanoacrylate (Gluebran®️) versus combined foam plus detachable coils
- Symptom severity reduction, assessed by the Pelvic Venous Clinical Severity Score (PVCSS) at baseline, 3, 6, 12, and 18 months.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start25 Aug 2025
- Primary completion25 Aug 2025
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Congestive SyndromeStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moustafa Hassan Mabrouk Abdelhameed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221695
- Sponsor's protocol ID
- glue vs coil for ovarian ttt
- Acronym
- foam and coil
- Status last verified
- Oct 2025
- First submitted
- 12 Oct 2025
- Last updated
- 28 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foam Plus Glue Versus Foam Plus Coils for Ovarian Vein Embolization in the Treatment of Pelvic Venous Disorders:
- ClinicalTrials.gov ID
- NCT07221695
- Acronym / sponsor ID
- foam and coil / glue vs coil for ovarian ttt
- Conditions
- Pelvic Congestive Syndrome
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 28 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Foam Plus Glue Versus Foam Plus Coils for Ovarian Vein Embolization in the Treatment of Pelvic Venous Disorders: A Randomized Controlled Trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Embolization using polidocanol foam followed by N-butyl cyanoacrylate | Active comparator | Other: Foam + N-butyl Cyanoacrylate. 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." |
| Combined Foam Sclerotherapy and Detachable Coil Embolization | Active comparator | Other: Combined Foam Sclerotherapy and Detachable Coil EmbolizationPatients 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foam + N-butyl Cyanoacrylate3% 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 | Embolization using polidocanol foam followed by N-butyl cyanoacrylate |
| Combined Foam Sclerotherapy and Detachable Coil Embolizationpolidocanol foam (as above), subsequently, detachable platinum fibered coils - specifically Interlock™ (Boston Scientific) or Concerto™ (Medtronic) | Other | Combined Foam Sclerotherapy and Detachable Coil Embolization |
Primary outcome
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
2. Symptom severity reduction, assessed by the Pelvic Venous Clinical Severity Score (PVCSS) at baseline, 3, 6, 12, and 18 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Individual participant dataSharing planned: Yes
Related trials for Pelvic Congestive Syndrome
Recruiting
Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
Chronic Pelvic Pain Syndrome, Pelvic Pain
RecruitingObservational study
Quantify the Degree of Pain Relief of Pelvic Congestion Syndrome Following Gonadal Vein Embolization
Pelvic Congestive Syndrome, Pelvic Pain
Enrolling by invitationObservational study
Development of a Patient-reported Outcome Measure for Women With Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome, Pelvic Congestive Syndrome
RecruitingObservational study
Study of Venous Outflow From the Lower Limbs in Patients With Pelvic Varicosities
Pelvic Varices, Varicose Veins of Lower Limb
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foam + N-butyl Cyanoacrylate and Combined Foam Sclerotherapy and Detachable Coil Embolization in people with Pelvic Congestive Syndrome, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.