VaricoceleNCT07764900
Transjugular and Transfemoral Embolization for Varicocele.
A study testing Percutaneous Varicocele Embolization Using N-Butyl Cyanoacrylate (NBCA) in people with Varicocele, run by Sohag University at 1 site in Egypt.
Trial summary
This prospective study will evaluate two different approaches for performing embolization to treat varicocele, a condition in which the veins around the testicle become enlarged. Read more about this study
- Who is it for?
- Ages 16 to 60 years, men only
- Conditions the study is for
- Varicocele
- What is being tested?
- Percutaneous Varicocele Embolization Using N-Butyl Cyanoacrylate (NBCA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2026to 10 May 2027
- 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 16 to 60 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1. Male patients aged 16-60 years. 2. Clinically palpable varicocele (Grade II or III) or subclinical varicocele associated with abnormal semen parameters.
- 3. Recurrent varicocele following previous surgical treatment. 4. Presence of scrotal pain, testicular atrophy, or infertility attributed to varicocele.
- 5. Willingness to participate in the study and provide written informed consent.
Who cannot join
- 1. Secondary varicocele due to a retroperitoneal mass or renal vein obstruction.
- 2. Known allergy to iodinated contrast media. 3. Coagulation disorders or contraindications to endovascular procedures.
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, 1 recruiting
- Recruiting
Sohag University - Faculty of Medicine
Sohag, Sohag Governorate, 82524
Arsanious Maher adib, MBBCh, +201287522810, arsanuoesmaher@gmail.com
About this study
Official title: Combined Role of Transjugular and Transfemoral Embolization in the Management of Varicocele.
This prospective study will evaluate two different approaches for performing embolization to treat varicocele, a condition in which the veins around the testicle become enlarged. Thirty patients with varicocele will undergo embolization using either a transjugular approach, through a vein in the neck, or a transfemoral approach, through a vein in the groin. The choice of approach will depend on the patient's venous anatomy and the feasibility of the procedure. Patients will be followed up at one and three months after the procedure to assess treatment effectiveness, symptom improvement, and any complications.
- Conditions
- Varicocele
- Being tested
- Percutaneous Varicocele Embolization Using N-Butyl Cyanoacrylate (NBCA)
- Medical subject headings
- Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Varicocele Embolization Using N-Butyl Cyanoacrylate (NBCA)Procedure or surgery
Percutaneous varicocele embolization will be performed under fluoroscopic guidance using a transvenous approach, either transfemoral or transjugular, according to the venous anatomy and operator preference. Selective catheterization of the internal spermatic vein will be performed, followed by embolization using N-butyl cyanoacrylate (NBCA) glue. Technical success will be assessed by completion venography demonstrating occlusion of the targeted varicocele veins and absence of significant residual venous reflux.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Varicocele Embolization | Experimental | Not described Receives: Procedure: Percutaneous Varicocele Embolization Using N-Butyl Cyanoacrylate (NBCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity Measured by the Visual Analog Scale (VAS).
Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. A decrease in the VAS score indicates improvement in pain. The change in VAS score from baseline to 1 month after varicocele embolization will be assessed.
Measured: 1 month after the procedure
Secondary outcomes (3)
Change in Pain Intensity Measured by the Visual Analog Scale (VAS) at 3 Months.
Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. A decrease in the VAS score indicates improvement in pain. The change in VAS score from baseline to 3 months after varicocele embolization will be assessed.
Measured: 3 months after the procedure
Change in Maximum Diameter of the Pampiniform Plexus Veins on Doppler Ultrasound
The maximum diameter of the pampiniform plexus veins will be measured using color and spectral Doppler ultrasound before and after varicocele embolization. A decrease in the maximum venous diameter indicates improvement. The change in venous diameter from baseline to 3 months after the procedure will be assessed.
Measured: 3 months after the procedure
Resolution of Venous Reflux on Doppler Ultrasound
Venous reflux will be assessed using color and spectral Doppler ultrasound. Resolution of reflux will be defined as the absence of demonstrable venous reflux after varicocele embolization. The presence or absence of venous reflux will be assessed at 3 months after the procedure.
Measured: 3 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start10 Apr 2026
- Primary completion10 Mar 2027 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arsanious Maher Adib, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764900
- Sponsor's protocol ID
- Soh-Med-26-7-2MS
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Role of Transjugular and Transfemoral Embolization in the Management of Varicocele.
- ClinicalTrials.gov ID
- NCT07764900
- Acronym / sponsor ID
- Soh-Med-26-7-2MS
- Conditions
- Varicocele
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 10 Mar 2027 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 14 Aug 2026 (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.
This prospective study will evaluate two different approaches for performing embolization to treat varicocele, a condition in which the veins around the testicle become enlarged. Thirty patients with varicocele will undergo embolization using either a transjugular approach, through a vein in the neck, or a transfemoral approach, through a vein in the groin. The choice of approach will depend on the patient's venous anatomy and the feasibility of the procedure. Patients will be followed up at one and three months after the procedure to assess treatment effectiveness, symptom improvement, and any complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Varicocele Embolization | Experimental | Procedure: Percutaneous Varicocele Embolization Using N-Butyl Cyanoacrylate (NBCA) |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 1. Male patients aged 16-60 years. 2. Clinically palpable varicocele (Grade II or III) or subclinical varicocele associated with abnormal semen parameters.
- 3. Recurrent varicocele following previous surgical treatment. 4. Presence of scrotal pain, testicular atrophy, or infertility attributed to varicocele.
- 5. Willingness to participate in the study and provide written informed consent.
Key exclusion criteria (2 listed)
- 1. Secondary varicocele due to a retroperitoneal mass or renal vein obstruction.
- 2. Known allergy to iodinated contrast media. 3. Coagulation disorders or contraindications to endovascular procedures.
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 |
|---|---|---|
| Percutaneous Varicocele Embolization Using N-Butyl Cyanoacrylate (NBCA)Percutaneous varicocele embolization will be performed under fluoroscopic guidance using a transvenous approach, either transfemoral or transjugular, according to the venous anatomy and operator preference. Selective catheterization of the internal spermatic vein will be performed, followed by embolization using N-butyl cyanoacrylate (NBCA) glue. Technical success will be assessed by completion venography demonstrating occlusion of the targeted varicocele veins and absence of significant residual venous reflux. | Procedure or surgery | Percutaneous Varicocele Embolization |
Primary outcome
Change in Pain Intensity Measured by the Visual Analog Scale (VAS).
Time frame: 1 month after the procedure
Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. A decrease in the VAS score indicates improvement in pain. The change in VAS score from baseline to 1 month after varicocele embolization will be assessed.
3 secondary outcomes
Change in Pain Intensity Measured by the Visual Analog Scale (VAS) at 3 Months.
Time frame: 3 months after the procedure
Change in Maximum Diameter of the Pampiniform Plexus Veins on Doppler Ultrasound
Time frame: 3 months after the procedure
Resolution of Venous Reflux on Doppler Ultrasound
Time frame: 3 months after the procedure
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 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Varicocele Embolization Using N-Butyl Cyanoacrylate (NBCA) in people with Varicocele, run by Sohag 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. 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?
Contact arsanious Maher adib, MBBCh (+201287522810, arsanuoesmaher@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity Measured by the Visual Analog Scale (VAS). (time frame: 1 month after the procedure). 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 14 Aug 2026.