HydroceleNCT04406077
The Use of Ligasure (r) for Hydrocelectomy Surgery
A study testing Ligasure in people with Hydrocele, run by Hillel Yaffe Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 81 years, men only
- Conditions the study is for
- Hydrocele
- What is being tested?
- Ligasure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Feb 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 81 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 81 males
- Diagnosed with unilateral hydrocele
Who cannot join
- Bilateral hydrocele
- infected hydrocele
- hydrocele secondary to tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Ligasure (r) for Cutting and Coagulations of Tissues in Hydrocelectomy Surgery
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.
Read the 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.
- Conditions
- Hydrocele
- Being tested
- Ligasure
- Medical subject headings
- Testicular Hydrocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LigasureDevice
Using ligasure to treat hydrocele
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients suffering from hydrocele, underwent treatment using Ligasure device. Receives: Device: Ligasure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three weeks after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start18 Feb 2018
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydroceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406077
- Sponsor's protocol ID
- 0117-17-HYMC
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Ligasure (r) for Cutting and Coagulations of Tissues in Hydrocelectomy Surgery
- ClinicalTrials.gov ID
- NCT04406077
- Acronym / sponsor ID
- 0117-17-HYMC
- Conditions
- Hydrocele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 18 Feb 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: LigasurePatients suffering from hydrocele, underwent treatment using Ligasure device. |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 - 81 males
- Diagnosed with unilateral hydrocele
Key exclusion criteria (3 listed)
- Bilateral hydrocele
- infected hydrocele
- hydrocele secondary to tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LigasureUsing ligasure to treat hydrocele | Device | Intervention |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ligasure in people with Hydrocele, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resolution of hydrocele (time frame: Three weeks after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.