NCT04406077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

1.9 years

First QC Date

May 6, 2020

Last Update Submit

May 26, 2020

Conditions

Hydrocele

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Intervention

EXPERIMENTAL

Patients suffering from hydrocele, underwent treatment using Ligasure device.

Device: Ligasure

Interventions

LigasureDEVICE

Using ligasure to treat hydrocele

Intervention

Eligibility Criteria

Age18 Years - 81 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • males
  • Diagnosed with unilateral hydrocele

You may not qualify if:

  • Bilateral hydrocele
  • infected hydrocele
  • hydrocele secondary to tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe MC,

Hadera, Israel

Location

MeSH Terms

Conditions

Testicular Hydrocele

Condition Hierarchy (Ancestors)

Testicular DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 28, 2020

Study Start

February 18, 2018

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

May 28, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)