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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04406077
Other study ID # 0117-17-HYMC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 18, 2018
Est. completion date December 30, 2019

Study information

Verified date May 2020
Source Hillel Yaffe Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hydrocele is a condition of fluid retention around the testes, which causes swallowing, pain, with interfering with the normal testes function. however, during activity, this can interfere with everyday activity (running, sexual intercourse). The treatment for hydrocele I surgical. The study aim to test the safety and efficacy of the Ligasure (r) device for cutting and coagulating tissues during hydrocelectomy.


Description:

Hydrocele is a condition of fluid retention around the testes, which causes swallowing, pain, with interfering with the normal testes function. however, during activity, this can interfere with everyday activity (running, sexual intercourse). The treatment for hydrocele I surgical. The study aim to test the safety and efficacy of the Ligasure (r) device for cutting and coagulating tissues during hydrocelectomy. during the study, males, 18 - 81 who suffer from hydrocele underwent hydrocelectomy using Ligasure (20 cm) without using sutures.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date December 30, 2019
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 81 Years
Eligibility Inclusion Criteria:

- 18 - 81 males

- Diagnosed with unilateral hydrocele

Exclusion Criteria:

- Bilateral hydrocele

- infected hydrocele

- hydrocele secondary to tumor

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ligasure
Using ligasure to treat hydrocele

Locations

Country Name City State
Israel Hillel Yaffe MC, Hadera

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary resolution of hydrocele The patients will undergo full urological physical exam to screen for signs of hydrocele. The testes size and manual palpation will be included in the assessment. Three weeks after the surgery
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