NCT07764900

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Apr 2026May 2027

Study Start

First participant enrolled

April 10, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2027

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

August 10, 2026

Last Update Submit

August 13, 2026

Conditions

Varicocele

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month after the procedure

Secondary Outcomes (3)

  • Change in Pain Intensity Measured by the Visual Analog Scale (VAS) at 3 Months.

    3 months after the procedure

  • Change in Maximum Diameter of the Pampiniform Plexus Veins on Doppler Ultrasound

    3 months after the procedure

  • Resolution of Venous Reflux on Doppler Ultrasound

    3 months after the procedure

Study Arms (1)

Percutaneous Varicocele Embolization

EXPERIMENTAL
Procedure: Percutaneous Varicocele Embolization Using N-Butyl Cyanoacrylate (NBCA)

Interventions

Percutaneous Varicocele Embolization Using N-Butyl Cyanoacrylate (NBCA)PROCEDURE

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.

Percutaneous Varicocele Embolization

Eligibility Criteria

Age16 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThe study will include male participants with clinically diagnosed varicocele who meet all other eligibility criteria.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \. Male patients aged 16-60 years. 2. Clinically palpable varicocele (Grade II or III) or subclinical varicocele associated with abnormal semen parameters.
  • \. Recurrent varicocele following previous surgical treatment. 4. Presence of scrotal pain, testicular atrophy, or infertility attributed to varicocele.
  • \. Willingness to participate in the study and provide written informed consent.

You may not qualify if:

  • \- 1. Secondary varicocele due to a retroperitoneal mass or renal vein obstruction.
  • \. Known allergy to iodinated contrast media. 3. Coagulation disorders or contraindications to endovascular procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University - Faculty of Medicine

Sohag, Sohag Governorate, 82524, Egypt

RECRUITING

MeSH Terms

Conditions

Varicocele

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

arsanious Maher adib, MBBCh

CONTACT

+201287522810arsanuoesmaher@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Diagnostic and Interventional Radiology

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 14, 2026

Study Start

April 10, 2026

Primary Completion (Estimated)

March 10, 2027

Study Completion (Estimated)

May 10, 2027

Last Updated

August 14, 2026

Record last verified: 2026-08

Locations

EG(1)