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

Sclerotherapy for hydro and spermatoceles with 99.5% Ethanol, an open clinical multicenter dose escalation study, phase 2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004630-38-SE

Enrollment

110

Registered

2020-10-08

Start date

2021-05-20

Completion date

Unknown

Last updated

2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydrocele and Spermatocele MedDRA version: 20.0 Level: PT Classification code 10020488 Term: Hydrocele System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0 Level: PT Classification code 10041490 Term: Spermatocele System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Product Name: Ethanol 99.5% Product Code: 356592 Pharmaceutical Form: Dental solution INN or Proposed INN: Ethanol CAS Number: 64-17-5 Current Sponsor code: Etanol APL Dentallösning 99,5% Other descri

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine systemic ethanol absorption as measured by alcometer results and blood tests To examine pain and complication rates 1-30 days from treatment;Secondary Objective: To examine cure rates with escalating doses of ethanol and exposure times;Primary end point(s): Systemic absorption of ethanol by injection into a water or sperm hernia at 2 different doses ;Timepoint(s) of evaluation of this end point: 5min, 30min, 1-4 days and 30 days from treatment.	—

Measure

Time frame

Main Objective: To examine systemic ethanol absorption as measured by alcometer results and blood tests To examine pain and complication rates 1-30 days from treatment;Secondary Objective: To examine cure rates with escalating doses of ethanol and exposure times;Primary end point(s): Systemic absorption of ethanol by injection into a water or sperm hernia at 2 different doses ;Timepoint(s) of evaluation of this end point: 5min, 30min, 1-4 days and 30 days from treatment.

—

Secondary

Measure	Time frame
Secondary end point(s): - Pain 1-4 days after treatment at 2 different doses - Complications within 30 days after treatment at 2 different doses - Symptom, 3 months after treatment at 2 different doses ;Timepoint(s) of evaluation of this end point: 1-4 days and 30 days and after three months from treatment	—

Countries

Sweden

Contacts

Public ContactÖstersunds sjukhus

Region Jämtland/Härjedalen

karl-johan.lundstrom@regionjh.se+4663153000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026