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The Use of Ligasure (r) for Hydrocelectomy Surgery

Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04406077
Collaborator
(none)
61
Enrollment
1
Location
1
Arm
22.3
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ligasure
 N/A

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
Actual Enrollment :
61 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Use of Ligasure (r) for Cutting and Coagulations of Tissues in Hydrocelectomy Surgery
Actual Study Start Date :
Feb 18, 2018
Actual Primary Completion Date :
Dec 30, 2019
Actual Study Completion Date :
Dec 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Patients suffering from hydrocele, underwent treatment using Ligasure device.

Device: Ligasure
Using ligasure to treat hydrocele

Outcome Measures

Primary Outcome Measures

  1. resolution of hydrocele [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 81 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 18 - 81 males

  • Diagnosed with unilateral hydrocele

Exclusion Criteria:

  • Bilateral hydrocele

  • infected hydrocele

  • hydrocele secondary to tumor

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hillel Yaffe MC, Hadera Israel

Sponsors and Collaborators

  • Hillel Yaffe Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT04406077
Other Study ID Numbers:
  • 0117-17-HYMC
First Posted:
May 28, 2020
Last Update Posted:
May 28, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Testicular Hydrocele

Study Results

No Results Posted as of May 28, 2020