Sclerotherapy for fluid filled cysts in the scrotum with 99.5% Alcohol

Phase 1

• Conditions: Hydrocele and Spermatocele; MedDRA version: 20.0Level: PTClassification code 10020488Term: HydroceleSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 20.0Level: PTClassification code 10041490Term: SpermatoceleSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2020-004630-38-SE
• Lead Sponsor: Region Jämtland/Härjedalen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-08
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 110

Inclusion Criteria

- Testicular hydrocele or spermatocele/epididymal cyst confirmed clinically or with ultrasound
- Informed consent to participate
- Symptomatic hydro or spermatocele corresponding to inconvenience that can not be ignored
- Patients wish to undergo treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

- Less hat 40 years
- Paternity wish
- Inability to comply with discontinuation of anticoagulants as described by the Swedish society of thrombosis and hemostasis
- Septated hydro or spermatocele on ultrasound
- Known allergy or hypersensitivity to the study drug.
- Mental inability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study
- Participates in or has recently participated in a recent clinical trial (30 days).
- Previous participation in this study.
- Treatment with immunostimulation drugs with ATC code L01FF (pembrolizumab, ipilimumab or equivalent).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified