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Clinical Trials/NCT04406077
NCT04406077CompletedNot Applicable

The Use of Ligasure (r) for Cutting and Coagulations of Tissues in Hydrocelectomy Surgery

Hillel Yaffe Medical Center1 site in 1 country61 target enrollmentStarted: February 18, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
61
Locations
1
Primary Endpoint
resolution of hydrocele

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 81 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 18 - 81 males
  • Diagnosed with unilateral hydrocele

Exclusion Criteria

  • Bilateral hydrocele
  • infected hydrocele
  • hydrocele secondary to tumor

Outcomes

Primary Outcomes

resolution of hydrocele

Time Frame: Three weeks after the surgery

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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